Trial Outcomes & Findings for Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes (NCT NCT01855412)
NCT ID: NCT01855412
Last Updated: 2023-07-18
Results Overview
Final post-procedural result of \<50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Recruitment status
COMPLETED
Target enrollment
1204 participants
Primary outcome timeframe
Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Results posted on
2023-07-18
Participant Flow
A subject was considered enrolled when a signed informed consent was in place and all inclusion/no exclusion criteria were met.
Participant milestones
| Measure |
Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
|---|---|---|---|
|
Overall Study
STARTED
|
501
|
603
|
100
|
|
Overall Study
COMPLETED
|
289
|
260
|
24
|
|
Overall Study
NOT COMPLETED
|
212
|
343
|
76
|
Reasons for withdrawal
| Measure |
Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
|---|---|---|---|
|
Overall Study
Death
|
77
|
123
|
30
|
|
Overall Study
Lost to Follow-up
|
28
|
46
|
15
|
|
Overall Study
Withdrawal by Subject
|
77
|
123
|
24
|
|
Overall Study
Physician Decision
|
25
|
31
|
3
|
|
Overall Study
Site Closure
|
4
|
18
|
1
|
|
Overall Study
Reason not Specified
|
1
|
2
|
3
|
Baseline Characteristics
Age was not collected for one subject in the CLI Rutherford 6 group.
Baseline characteristics by cohort
| Measure |
Claudication (Rutherford 2-3)
n=500 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5
n=589 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6
n=100 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
Total
n=1189 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 10.0 • n=500 Participants • Age was not collected for one subject in the CLI Rutherford 6 group.
|
70.3 years
STANDARD_DEVIATION 10.9 • n=589 Participants • Age was not collected for one subject in the CLI Rutherford 6 group.
|
68.0 years
STANDARD_DEVIATION 13.0 • n=99 Participants • Age was not collected for one subject in the CLI Rutherford 6 group.
|
69.8 years
STANDARD_DEVIATION 10.7 • n=1188 Participants • Age was not collected for one subject in the CLI Rutherford 6 group.
|
|
Sex: Female, Male
Female
|
167 Participants
n=500 Participants
|
225 Participants
n=589 Participants
|
27 Participants
n=100 Participants
|
419 Participants
n=1189 Participants
|
|
Sex: Female, Male
Male
|
333 Participants
n=500 Participants
|
364 Participants
n=589 Participants
|
73 Participants
n=100 Participants
|
770 Participants
n=1189 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
77 Participants
n=500 Participants
|
63 Participants
n=589 Participants
|
29 Participants
n=100 Participants
|
169 Participants
n=1189 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
423 Participants
n=500 Participants
|
526 Participants
n=589 Participants
|
71 Participants
n=100 Participants
|
1020 Participants
n=1189 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=500 Participants
|
0 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=1189 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
411 Participants
n=500 Participants
|
483 Participants
n=589 Participants
|
78 Participants
n=100 Participants
|
972 Participants
n=1189 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
68 Participants
n=500 Participants
|
89 Participants
n=589 Participants
|
21 Participants
n=100 Participants
|
178 Participants
n=1189 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=500 Participants
|
1 Participants
n=589 Participants
|
1 Participants
n=100 Participants
|
7 Participants
n=1189 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=500 Participants
|
1 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=1189 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=500 Participants
|
4 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
5 Participants
n=1189 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=500 Participants
|
11 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
25 Participants
n=1189 Participants
|
|
Region of Enrollment
United States
|
500 participants
n=500 Participants
|
589 participants
n=589 Participants
|
100 participants
n=100 Participants
|
1189 participants
n=1189 Participants
|
|
Baseline Rutherford Classification (RC)
RC 2
|
97 Participants
n=500 Participants
|
0 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
97 Participants
n=1189 Participants
|
|
Baseline Rutherford Classification (RC)
RC 3
|
403 Participants
n=500 Participants
|
0 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
403 Participants
n=1189 Participants
|
|
Baseline Rutherford Classification (RC)
RC 4
|
0 Participants
n=500 Participants
|
285 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
285 Participants
n=1189 Participants
|
|
Baseline Rutherford Classification (RC)
RC 5
|
0 Participants
n=500 Participants
|
304 Participants
n=589 Participants
|
0 Participants
n=100 Participants
|
304 Participants
n=1189 Participants
|
|
Baseline Rutherford Classification (RC)
RC 6
|
0 Participants
n=500 Participants
|
0 Participants
n=589 Participants
|
100 Participants
n=100 Participants
|
100 Participants
n=1189 Participants
|
PRIMARY outcome
Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hoursPopulation: Analysis population consists of data from 1,106 enrolled subjects with sufficient information to assess procedural success. Fifteen subjects were excluded due to site closure and lack of investigator signature, 83 subjects were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.
Final post-procedural result of \<50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Outcome measures
| Measure |
Claudication (Rutherford 2-3)
n=469 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5
n=545 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6
n=92 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
|---|---|---|---|
|
Procedural Success of Endovascular PAD Treatment(s)
|
83.6 percent of procedures
Interval 79.9 to 86.8
|
75.8 percent of procedures
Interval 72.0 to 79.3
|
68.5 percent of procedures
Interval 58.0 to 77.8
|
PRIMARY outcome
Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hoursPopulation: Analysis population consists of data from 1,452 treated lesions with sufficient information to assess procedural success. Data from fifteen subjects were excluded due to site closure and lack of investigator signature; 76 lesions were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.
Final post-procedural result of \<50% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.
Outcome measures
| Measure |
Claudication (Rutherford 2-3)
n=578 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5
n=733 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6
n=141 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
|---|---|---|---|
|
Lesion Success of Endovascular PAD Treatment(s)
|
84.9 percent of lesions treated
Interval 81.9 to 88.0
|
79.1 percent of lesions treated
Interval 75.8 to 82.1
|
75.2 percent of lesions treated
Interval 66.8 to 82.2
|
PRIMARY outcome
Timeframe: One (1) year and three (3) years post-procedurePopulation: Analysis population consists of data from 1,189 enrolled subjects with Investigator signed baseline and procedure patient records. Due to site closure and lack of Investigator signature, 15 subjects were excluded in the cohort.
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years. 1- and 3-year MAE is composed of: * Death within 30 days of index procedure * Unplanned major (above the ankle) amputation of the target limb * Clinically-driven TVR (Target Vessel Revascularization) of the target limb
Outcome measures
| Measure |
Claudication (Rutherford 2-3)
n=500 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5
n=589 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6
n=100 Participants
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
|---|---|---|---|
|
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
Freedom from MAE at 1-Year
|
82.1 percent probability of freedom from MAE
Interval 78.6 to 85.7
|
73.2 percent probability of freedom from MAE
Interval 69.4 to 77.0
|
59.3 percent probability of freedom from MAE
Interval 48.4 to 70.1
|
|
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
Freedom from MAE at 3-Years
|
70.3 percent probability of freedom from MAE
Interval 65.9 to 74.7
|
62.0 percent probability of freedom from MAE
Interval 57.5 to 66.5
|
47.4 percent probability of freedom from MAE
Interval 34.7 to 60.0
|
Adverse Events
Claudication Rutherford 2-3 Procedure Through 30 Days
Serious events: 72 serious events
Other events: 28 other events
Deaths: 2 deaths
CLI Rutherford 4-5 Procedure Through 30 Days
Serious events: 112 serious events
Other events: 31 other events
Deaths: 2 deaths
CLI Rutherford 6 Procedure Through 30 Days
Serious events: 24 serious events
Other events: 2 other events
Deaths: 4 deaths
Rutherford 2-3 31 Days - 365 Days Post-Procedure
Serious events: 145 serious events
Other events: 0 other events
Deaths: 18 deaths
CLI Rutherford 4-5 31 Days - 365 Days Post-Procedure
Serious events: 249 serious events
Other events: 0 other events
Deaths: 40 deaths
CLI Rutherford 6 31 Days - 365 Days Post-Procedure
Serious events: 40 serious events
Other events: 0 other events
Deaths: 17 deaths
Claudication Rutherford 2-3 366 Days Post-Procedure or Greater
Serious events: 167 serious events
Other events: 0 other events
Deaths: 57 deaths
CLI Rutherford 4-5 366 Days Post-Procedure or Greater
Serious events: 227 serious events
Other events: 0 other events
Deaths: 81 deaths
CLI Rutherford 6 366 Days Post-Procedure or Greater
Serious events: 24 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Claudication Rutherford 2-3 Procedure Through 30 Days
n=501 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5 Procedure Through 30 Days
n=603 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6 Procedure Through 30 Days
n=100 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
Rutherford 2-3 31 Days - 365 Days Post-Procedure
n=501 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
|
CLI Rutherford 4-5 31 Days - 365 Days Post-Procedure
n=603 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
|
CLI Rutherford 6 31 Days - 365 Days Post-Procedure
n=100 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
|
Claudication Rutherford 2-3 366 Days Post-Procedure or Greater
n=501 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
|
CLI Rutherford 4-5 366 Days Post-Procedure or Greater
n=603 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
|
CLI Rutherford 6 366 Days Post-Procedure or Greater
n=100 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmias
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Cardiac disorders
Cardiac dysfunction - Chronic heart failure or aggravated
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.50%
3/603 • Number of events 3 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.60%
3/501 • Number of events 3 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
|
Cardiac disorders
Cardiac/cardiopulmonary arrest
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
3.0%
3/100 • Number of events 3 • Index procedure through 5 years
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.66%
4/603 • Number of events 4 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.80%
4/501 • Number of events 4 • Index procedure through 5 years
|
1.5%
9/603 • Number of events 9 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Cardiac disorders
Coronary artery thrombus/thrombosis
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/501 • Index procedure through 5 years
|
1.00%
6/603 • Number of events 6 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.60%
3/501 • Number of events 3 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.66%
4/603 • Number of events 4 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Cardiac disorders
Other cardiac
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
2.0%
2/100 • Number of events 2 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
|
Gastrointestinal disorders
Gastrointestional infection/inflammation
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Gastrointestinal disorders
Other digestive disorders
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
General disorders
Allergic reaction
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
General disorders
Blood and lymphatic system disorder-anemia
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
General disorders
Cancer
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.60%
3/501 • Number of events 3 • Index procedure through 5 years
|
1.00%
6/603 • Number of events 6 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
General disorders
Compartment syndrome
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
|
General disorders
Death-unknown cause
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.80%
4/501 • Number of events 4 • Index procedure through 5 years
|
1.7%
10/603 • Number of events 10 • Index procedure through 5 years
|
7.0%
7/100 • Number of events 7 • Index procedure through 5 years
|
3.8%
19/501 • Number of events 19 • Index procedure through 5 years
|
3.8%
23/603 • Number of events 23 • Index procedure through 5 years
|
4.0%
4/100 • Number of events 4 • Index procedure through 5 years
|
|
General disorders
Infection-Systemic
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
1.00%
6/603 • Number of events 6 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.66%
4/603 • Number of events 4 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
General disorders
Injury/trauma
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
General disorders
Multi-organ failure
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.80%
4/501 • Number of events 4 • Index procedure through 5 years
|
0.83%
5/603 • Number of events 5 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
|
General disorders
Other adverse event
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.50%
3/603 • Number of events 3 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
General disorders
Shock
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
|
Hepatobiliary disorders
Hepatic-biliary system disorders (e.g. liver, bile duct)
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Other peripheral procedural complication
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.66%
4/603 • Number of events 4 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral arteriovenous fistula
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery abrupt closure
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery dissection
|
8.6%
43/501 • Number of events 46 • Index procedure through 5 years
|
4.6%
28/603 • Number of events 30 • Index procedure through 5 years
|
2.0%
2/100 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery distal embolization
|
0.60%
3/501 • Number of events 3 • Index procedure through 5 years
|
0.83%
5/603 • Number of events 7 • Index procedure through 5 years
|
2.0%
2/100 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery no reflow
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery perforation
|
1.4%
7/501 • Number of events 7 • Index procedure through 5 years
|
1.2%
7/603 • Number of events 8 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery pseudoaneurysm
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery slow flow
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery thrombus/thrombosis
|
1.2%
6/501 • Number of events 6 • Index procedure through 5 years
|
1.8%
11/603 • Number of events 11 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery vasospasm
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.50%
3/603 • Number of events 3 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Nervous system disorders
Cerebrovascular accident (CVA)
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Nervous system disorders
Other neuro/pshychiatric disorders
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Nervous system disorders
Stroke
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Renal and urinary disorders
Chronic renal failure or worsened
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.66%
4/603 • Number of events 4 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
1.00%
6/603 • Number of events 6 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Bleeding/hemorrhage non-access site
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Bleeding/hemorrhage, access site
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.66%
4/603 • Number of events 4 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Bruising/hematoma access site
|
0.40%
2/501 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Embolism, pulmonary
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/501 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
New/worsening infection
|
0.00%
0/501 • Index procedure through 5 years
|
1.3%
8/603 • Number of events 8 • Index procedure through 5 years
|
6.0%
6/100 • Number of events 6 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
4.5%
27/603 • Number of events 30 • Index procedure through 5 years
|
9.0%
9/100 • Number of events 9 • Index procedure through 5 years
|
0.80%
4/501 • Number of events 6 • Index procedure through 5 years
|
2.8%
17/603 • Number of events 17 • Index procedure through 5 years
|
4.0%
4/100 • Number of events 6 • Index procedure through 5 years
|
|
Vascular disorders
New/worsening pain
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.50%
3/603 • Number of events 3 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 2 • Index procedure through 5 years
|
0.50%
3/603 • Number of events 3 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
New/worsening wound
|
0.00%
0/501 • Index procedure through 5 years
|
1.8%
11/603 • Number of events 12 • Index procedure through 5 years
|
10.0%
10/100 • Number of events 11 • Index procedure through 5 years
|
1.00%
5/501 • Number of events 6 • Index procedure through 5 years
|
3.5%
21/603 • Number of events 24 • Index procedure through 5 years
|
11.0%
11/100 • Number of events 14 • Index procedure through 5 years
|
1.8%
9/501 • Number of events 11 • Index procedure through 5 years
|
2.5%
15/603 • Number of events 21 • Index procedure through 5 years
|
2.0%
2/100 • Number of events 2 • Index procedure through 5 years
|
|
Vascular disorders
Other peripheral vascular disorder
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Other vascular disorder
|
0.00%
0/501 • Index procedure through 5 years
|
0.17%
1/603 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.20%
1/501 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
|
Vascular disorders
Peripheral artery restenosis
|
0.20%
1/501 • Number of events 1 • Index procedure through 5 years
|
2.5%
15/603 • Number of events 17 • Index procedure through 5 years
|
2.0%
2/100 • Number of events 2 • Index procedure through 5 years
|
16.0%
80/501 • Number of events 107 • Index procedure through 5 years
|
21.7%
131/603 • Number of events 212 • Index procedure through 5 years
|
18.0%
18/100 • Number of events 23 • Index procedure through 5 years
|
17.0%
85/501 • Number of events 160 • Index procedure through 5 years
|
21.6%
130/603 • Number of events 326 • Index procedure through 5 years
|
10.0%
10/100 • Number of events 17 • Index procedure through 5 years
|
|
Vascular disorders
Peripheral artery stenosis
|
1.2%
6/501 • Number of events 6 • Index procedure through 5 years
|
3.0%
18/603 • Number of events 20 • Index procedure through 5 years
|
2.0%
2/100 • Number of events 2 • Index procedure through 5 years
|
14.2%
71/501 • Number of events 89 • Index procedure through 5 years
|
21.4%
129/603 • Number of events 164 • Index procedure through 5 years
|
11.0%
11/100 • Number of events 11 • Index procedure through 5 years
|
15.2%
76/501 • Number of events 102 • Index procedure through 5 years
|
15.8%
95/603 • Number of events 132 • Index procedure through 5 years
|
4.0%
4/100 • Number of events 5 • Index procedure through 5 years
|
|
Vascular disorders
Peripheral artery/vascular disease
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
1.0%
1/100 • Number of events 1 • Index procedure through 5 years
|
|
Vascular disorders
Peripheral thrombus/thrombosis
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.33%
2/603 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
Other adverse events
| Measure |
Claudication Rutherford 2-3 Procedure Through 30 Days
n=501 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 4-5 Procedure Through 30 Days
n=603 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
CLI Rutherford 6 Procedure Through 30 Days
n=100 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
|
Rutherford 2-3 31 Days - 365 Days Post-Procedure
n=501 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
|
CLI Rutherford 4-5 31 Days - 365 Days Post-Procedure
n=603 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
|
CLI Rutherford 6 31 Days - 365 Days Post-Procedure
n=100 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
|
Claudication Rutherford 2-3 366 Days Post-Procedure or Greater
n=501 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
|
CLI Rutherford 4-5 366 Days Post-Procedure or Greater
n=603 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
|
CLI Rutherford 6 366 Days Post-Procedure or Greater
n=100 participants at risk
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
|
|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Peripheral artery dissection
|
5.6%
28/501 • Number of events 29 • Index procedure through 5 years
|
5.1%
31/603 • Number of events 35 • Index procedure through 5 years
|
2.0%
2/100 • Number of events 2 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
0.00%
0/501 • Index procedure through 5 years
|
0.00%
0/603 • Index procedure through 5 years
|
0.00%
0/100 • Index procedure through 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60