Trial Outcomes & Findings for Disrupt CAD III With the Shockwave Coronary IVL System (NCT NCT03595176)
NCT ID: NCT03595176
Last Updated: 2023-05-19
Results Overview
The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
431 participants
Primary outcome timeframe
within 30 days of index procedure
Results posted on
2023-05-19
Participant Flow
Study recruitment and enrollment took place at 47 global centers including 38 in the United States and 9 in Europe between January 9, 2019 and March 27, 2020. A total of 431 subjects with de novo, calcified, stenotic, coronary arteries were enrolled and treated with the Coronary Intravascular Lithotripsy (IVL) System.
431 subjects were enrolled into the study. The definition of enrollment is when the subject signs informed consent, meets all inclusion criteria, none of the exclusion criteria, and the IVL catheter has been inserted over a 0.014 guidewire which had been previously passed across the study lesion.
Participant milestones
| Measure |
Coronary IVL System (Roll-In)
The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
|
Coronary IVL System (Pivotal)
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
384
|
|
Overall Study
COMPLETED
|
47
|
381
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Coronary IVL System (Roll-In)
The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
|
Coronary IVL System (Pivotal)
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Disrupt CAD III With the Shockwave Coronary IVL System
Baseline characteristics by cohort
| Measure |
Coronary IVL System (Roll-In)
n=47 Participants
The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
|
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 7.6 • n=39 Participants
|
71.2 years
STANDARD_DEVIATION 8.6 • n=41 Participants
|
71.1 years
STANDARD_DEVIATION 8.5 • n=35 Participants
|
|
Age, Customized
Median (Q1, Q3)
|
72.0 years
n=39 Participants
|
71.0 years
n=41 Participants
|
71.0 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
90 Participants
n=41 Participants
|
102 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=39 Participants
|
294 Participants
n=41 Participants
|
329 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=39 Participants
|
330 Participants
n=41 Participants
|
371 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=39 Participants
|
318 Participants
n=41 Participants
|
353 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=39 Participants
|
335 Participants
n=41 Participants
|
373 Participants
n=35 Participants
|
|
Region of Enrollment
Europe
|
9 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
58 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Primary Outcome Measure; therefore, only pivotal group is reported. Additionally, one subject was excluded from the primary safety endpoint analysis due to insufficient follow-up (\<23 days).
The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=383 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure
|
92.2 percentage of participants
Interval 89.9 to
The hypothesis test was a one-sided asymptotic Wald (normal approximation-based) confidence interval for a binomial proportion against a performance goal.
|
PRIMARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Primary Outcome Measure; therefore, only pivotal group is reported.
The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis \<50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Number of Participants With Procedural Success (Residual Stenosis <50%)
|
92.4 percentage of participants
Interval 90.2 to
The hypothesis test was a one-sided asymptotic Wald (normal approximation-based) confidence interval for a binomial proportion against a performance goal.
|
SECONDARY outcome
Timeframe: at end of procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Device Crossing Success defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Number of Participants With Device Crossing Success
|
368 Participants
|
SECONDARY outcome
Timeframe: at end of procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Angiographic Success defined as stent delivery with \<50% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Number of Participants With Angiographic Success (Residual Stenosis <50%)
|
370 Participants
|
SECONDARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Procedural Success defined as stent delivery with a residual stenosis \<=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Number of Participants With Procedural Success (Residual Stenosis <=30%)
|
354 Participants
|
SECONDARY outcome
Timeframe: at end of procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Angiographic Success defined as stent delivery with \<=30% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Number of Participants With Angiographic Success (Residual Stenosis <=30%)
|
369 Participants
|
SECONDARY outcome
Timeframe: at end of procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Serious Angiographic Complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Number of Participants With Serious Angiographic Complications
|
12 Participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
MACE at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
MACE Rate at 6 Months
|
10.2 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
MACE at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
MACE Rate at 12 Months
|
13.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
MACE at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
MACE Rate at 24 Months
|
18.9 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Target lesion failure (TLF) is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Target Lesion Failure (TLF) Rate at 30 Days
|
7.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Target Lesion Failure (TLF) Rate at 6 Months
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Target Lesion Failure (TLF) Rate at 12 Months
|
11.9 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Target Lesion Failure (TLF) Rate at 24 Months
|
16.1 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
All-Cause Death Rate at 30 Days
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
All-cause death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
All-Cause Death Rate at 6 Months
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
All-cause death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
All-Cause Death Rate at 12 Months
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
All-cause death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
All-Cause Death Rate at 24 Months
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Cardiac Death Rate at 30 Days
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Cardiac death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Cardiac Death Rate at 6 Months
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Cardiac death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Cardiac Death Rate at 12 Months
|
1.1 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Cardiac death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Cardiac Death Rate at 24 Months
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
MI Rate at 30 Days
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
MI Rate at 6 Months
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
MI Rate at 12 Months
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
MI Rate at 24 Months
|
12.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
TV-MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
TV-MI Rate at 6 Months
|
7.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
TV-MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
TV-MI Rate at 12 Months
|
7.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
TV-MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
TV-MI Rate at 24 Months
|
8.1 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Periprocedural MI defined as CK-MB \> 3x upper limit of lab normal (ULN). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Procedural MI Rate at 30 Days
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Periprocedural MI defined as CK-MB \> 3x upper limit of lab normal (ULN). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Procedural MI Rate at 6 Months
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Periprocedural MI defined as CK-MB \> 3x upper limit of lab normal (ULN). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Procedural MI Rate at 12 Months
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Periprocedural MI defined as CK-MB \> 3x upper limit of lab normal (ULN). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Procedural MI Rate at 24 Months
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-Procedural MI Rate at 30 Days
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-Procedural MI Rate at 6 Months
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-Procedural MI Rate at 12 Months
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-Procedural MI Rate at 24 Months
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
ID-TVR Rate at 6 Months
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
ID-TVR Rate at 12 Months
|
6.0 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
ID-TVR Rate at 24 Months
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
ID-TLR Rate at 6 Months
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
ID-TLR Rate at 12 Months
|
4.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
ID-TLR Rate at 24 Months
|
6.4 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TVR Rate at 30 Days
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TVR Rate at 6 Months
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TVR Rate at 12 Months
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TVR Rate at 24 Months
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TLR Rate at 30 Days
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TLR Rate at 6 Months
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TLR Rate at 12 Months
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Non-ID-TLR Rate at 24 Months
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any revascularizations (ID and non-ID) at 30 days. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Any Revascularizations Rate at 30 Days
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any revascularizations (ID and non-ID) at 6 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Any Revascularizations Rate at 6 Months
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any revascularizations (ID and non-ID) at 12 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Any Revascularizations Rate at 12 Months
|
12.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any revascularizations (ID and non-ID) at 24 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Any Revascularizations Rate at 24 Months
|
15.4 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Stent Thrombosis Rate at 30 Days
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Stent Thrombosis Rate at 6 Months
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Stent Thrombosis Rate at 12 Months
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Stent Thrombosis Rate at 24 Months
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the 4th Universal Definition at 30 Days
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the 4th Universal Definition at 6 Months
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the 4th Universal Definition at 12 Months
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the 4th Universal Definition at 24 Months
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the SCAI Definition at 6 Months
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 12 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the SCAI Definition at 12 Months
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 months of index procedurePopulation: Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only pivotal group is reported.
For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
Outcome measures
| Measure |
Coronary IVL System (Pivotal)
n=384 Participants
The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is complete.
|
|---|---|
|
Rate of MI Using the SCAI Definition at 24 Months
|
2.6 percentage of participants
|
Adverse Events
Coronary IVL System (Roll-In) Through 30 Days
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Coronary IVL System (Pivotal) Through 30 Days
Serious events: 54 serious events
Other events: 54 other events
Deaths: 2 deaths
Coronary IVL System (Pivotal) Through 12 Months
Serious events: 136 serious events
Other events: 140 other events
Deaths: 7 deaths
Coronary IVL System (Pivotal) Through 24 Months
Serious events: 173 serious events
Other events: 162 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Coronary IVL System (Roll-In) Through 30 Days
n=47 participants at risk
Adverse events reported through 30 days post-procedure for Roll-In subjects. The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
|
Coronary IVL System (Pivotal) Through 30 Days
n=384 participants at risk
Adverse events reported through 30 days post-procedure for Pivotal subjects. The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints.
|
Coronary IVL System (Pivotal) Through 12 Months
n=384 participants at risk
Adverse events reported through 12 months post-procedure for Pivotal subjects. Adverse event data on pivotal subjects was collected through 12 months for long-term follow-up.
|
Coronary IVL System (Pivotal) Through 24 Months
n=384 participants at risk
Adverse events reported through 24 months post-procedure for Pivotal subjects. Adverse event data on pivotal subjects was collected through 24 months for long-term follow-up.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Coronary artery dissection
|
2.1%
1/47 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.9%
11/384 • Number of events 11 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.9%
11/384 • Number of events 11 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.9%
11/384 • Number of events 11 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.1%
8/384 • Number of events 10 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.2%
16/384 • Number of events 18 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
6.2%
24/384 • Number of events 27 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.6%
6/384 • Number of events 10 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
3.9%
15/384 • Number of events 20 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.9%
19/384 • Number of events 26 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
3.9%
15/384 • Number of events 21 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.4%
17/384 • Number of events 23 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.6%
6/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.1%
1/47 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.6%
6/384 • Number of events 8 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Congenital, familial and genetic disorders
Congenital coronary artery malformation
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.1%
8/384 • Number of events 9 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.3%
9/384 • Number of events 10 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Pain
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Pyrexia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Sepsis
|
2.1%
1/47 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.6%
6/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.9%
11/384 • Number of events 11 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Investigations
Myocardial necrosis marker increased (elevated cardiac biomarker)
|
2.1%
1/47 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Seizure
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/47 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.1%
8/384 • Number of events 8 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.6%
10/384 • Number of events 11 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
3.9%
15/384 • Number of events 17 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Hypertension
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Hypotension
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Shock
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.1%
1/47 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.6%
6/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Plaque shift
|
2.1%
1/47 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 7 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Asthenia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Infection
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
3.6%
14/384 • Number of events 15 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
6.2%
24/384 • Number of events 26 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.3%
9/384 • Number of events 9 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Syncope
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 7 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.6%
6/384 • Number of events 7 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.6%
6/384 • Number of events 6 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.3%
5/384 • Number of events 5 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.8%
7/384 • Number of events 7 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Embolism
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Blood and lymphatic system disorders
Nomocytic anaemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Endocrine disorders
Goitre
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Injury, poisoning and procedural complications
Transfusion-related circulatory overload
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eccrine carcinoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.78%
3/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.52%
2/384 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.00%
0/384 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
Other adverse events
| Measure |
Coronary IVL System (Roll-In) Through 30 Days
n=47 participants at risk
Adverse events reported through 30 days post-procedure for Roll-In subjects. The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
|
Coronary IVL System (Pivotal) Through 30 Days
n=384 participants at risk
Adverse events reported through 30 days post-procedure for Pivotal subjects. The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints.
|
Coronary IVL System (Pivotal) Through 12 Months
n=384 participants at risk
Adverse events reported through 12 months post-procedure for Pivotal subjects. Adverse event data on pivotal subjects was collected through 12 months for long-term follow-up.
|
Coronary IVL System (Pivotal) Through 24 Months
n=384 participants at risk
Adverse events reported through 24 months post-procedure for Pivotal subjects. Adverse event data on pivotal subjects was collected through 24 months for long-term follow-up.
|
|---|---|---|---|---|
|
Investigations
Myocardial necrosis marker increased (elevated cardiac biomarker)
|
21.3%
10/47 • Number of events 12 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
14.1%
54/384 • Number of events 60 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
14.8%
57/384 • Number of events 64 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
15.1%
58/384 • Number of events 66 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Angina pectoris
|
6.4%
3/47 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.4%
17/384 • Number of events 18 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
9.6%
37/384 • Number of events 40 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
11.2%
43/384 • Number of events 52 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Coronary artery dissection
|
6.4%
3/47 • Number of events 3 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.7%
18/384 • Number of events 18 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.7%
18/384 • Number of events 18 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.7%
18/384 • Number of events 18 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.2%
16/384 • Number of events 18 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
8.3%
32/384 • Number of events 38 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
8.9%
34/384 • Number of events 42 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.8%
7/384 • Number of events 8 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
6.5%
25/384 • Number of events 26 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
7.6%
29/384 • Number of events 34 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
Infections and infestations
Infection
|
2.1%
1/47 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
0.26%
1/384 • Number of events 1 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
6.5%
25/384 • Number of events 27 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
7.8%
30/384 • Number of events 34 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/47 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
2.6%
10/384 • Number of events 11 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
4.9%
19/384 • Number of events 21 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
6.0%
23/384 • Number of events 27 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
|
General disorders
Fatigue
|
4.3%
2/47 • Number of events 2 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
1.0%
4/384 • Number of events 4 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
3.6%
14/384 • Number of events 14 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
5.5%
21/384 • Number of events 22 • within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only
Long-term follow-up for pivotal subjects to 24 months is complete.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60