Trial Outcomes & Findings for Post-Approval Study for the FLAIR Endovascular Stent Graft (NCT NCT00677235)
NCT ID: NCT00677235
Last Updated: 2017-03-10
Results Overview
To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.
COMPLETED
NA
270 participants
12 months
2017-03-10
Participant Flow
Participant milestones
| Measure |
FLAIR
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
132
|
|
Overall Study
COMPLETED
|
97
|
94
|
|
Overall Study
NOT COMPLETED
|
41
|
38
|
Reasons for withdrawal
| Measure |
FLAIR
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Death
|
37
|
36
|
|
Overall Study
Adverse Experience
|
1
|
0
|
Baseline Characteristics
Post-Approval Study for the FLAIR Endovascular Stent Graft
Baseline characteristics by cohort
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
63 years
n=107 Participants
|
63.5 years
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
138 participants
n=99 Participants
|
132 participants
n=107 Participants
|
270 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).
To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.
|
0.240 proportion of participants
Interval 0.165 to 0.315
|
0.110 proportion of participants
Interval 0.054 to 0.167
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.
The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.
|
5.2 Months/intervention
Standard Deviation 4.08
|
4.4 Months/intervention
Standard Deviation 3.51
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
FLAIR
n=128 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=130 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.
|
128 Number of Participants with Device and/o
|
130 Number of Participants with Device and/o
|
SECONDARY outcome
Timeframe: Patient Follow-UpThe estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure
|
1.9 reinterventions
Standard Deviation 2.18
|
2.4 reinterventions
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: 12 monthsPostintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Post-Intervention Assisted Primary Patency at 12 Months
|
0.497 proportion of participants
Interval 0.41 to 0.584
|
0.563 proportion of participants
Interval 0.474 to 0.653
|
SECONDARY outcome
Timeframe: 12 monthsPostintervention secondary patency \[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Post-intervention Secondary Patency (PSP) at 12 Months
|
0.653 proportion of participants
Interval 0.569 to 0.736
|
0.710 proportion of participants
Interval 0.629 to 0.792
|
SECONDARY outcome
Timeframe: Patient Follow-UpProcedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Procedural Success
|
81.2 Percentage of Participants
|
75.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Patient Follow-UpThe incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure
|
2 events
|
0 events
|
SECONDARY outcome
Timeframe: 12 monthsSerious Adverse Events at 12 months are reported for all 270 subjects.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months
|
60.9 percentage of participants with serious
|
65.9 percentage of participants with serious
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).
Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.
|
0.095 proportion of participants
Interval 0.029 to 0.162
|
0.055 proportion of participants
Interval 0.013 to 0.097
|
SECONDARY outcome
Timeframe: 24 monthsTo estimate the percentage of participants without safety issues through 24 months.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
To Estimate Safety at 24 Months.
|
10.9 percentage of participants
|
3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 month follow upPostintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Post-Intervention Assisted Primary Patency at 24 Months
|
0.384 proportion of participants
Interval 0.282 to 0.486
|
0.406 proportion of participants
Interval 0.312 to 0.5
|
SECONDARY outcome
Timeframe: 24 monthsPostintervention secondary patency \[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Post-intervention Secondary Patency at 24 Months
|
0.518 proportion of participants
Interval 0.41 to 0.626
|
0.574 proportion of participants
Interval 0.481 to 0.668
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.
The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.
|
7.1 Months/intervention
Standard Deviation 7.04
|
5.3 Months/intervention
Standard Deviation 5.22
|
SECONDARY outcome
Timeframe: 6 month follow upPostintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Post-Intervention Assisted Primary Patency at 6 Months
|
0.596 proportion of participants
Interval 0.512 to 0.681
|
0.656 proportion of participants
Interval 0.573 to 0.74
|
SECONDARY outcome
Timeframe: 6 month follow-upPostintervention secondary patency \[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Post-intervention Secondary Patency at 6 Months
|
0.748 proportion of participants
Interval 0.673 to 0.822
|
0.793 proportion of participants
Interval 0.722 to 0.864
|
POST_HOC outcome
Timeframe: 12 months follow upTAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Treatment Area Primary Patency (TAPP) at 12 Months.
|
0.476 proportion of participants
Interval 0.389 to 0.564
|
0.248 proportion of participants
Interval 0.17 to 0.325
|
POST_HOC outcome
Timeframe: 24 months follow-upTAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.
Outcome measures
| Measure |
FLAIR
n=138 Participants
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 Participants
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Treatment Area Primary Patency (TAPP) at 24 Months.
|
0.269 proportion of participants
Interval 0.177 to 0.36
|
0.135 proportion of participants
Interval 0.068 to 0.202
|
Adverse Events
FLAIR
PTA Only
Serious adverse events
| Measure |
FLAIR
n=138 participants at risk
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 participants at risk
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Cardiac disorders
Cerebrovascular accident
|
1.4%
2/138 • Number of events 2 • From Index Procedure through 24 months of follow-up.
|
3.8%
5/132 • Number of events 5 • From Index Procedure through 24 months of follow-up.
|
|
Cardiac disorders
Congestive heart failure
|
3.6%
5/138 • Number of events 5 • From Index Procedure through 24 months of follow-up.
|
3.8%
5/132 • Number of events 5 • From Index Procedure through 24 months of follow-up.
|
|
Blood and lymphatic system disorders
hemotoma
|
1.4%
2/138 • Number of events 2 • From Index Procedure through 24 months of follow-up.
|
0.00%
0/132 • From Index Procedure through 24 months of follow-up.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
4.3%
6/138 • Number of events 6 • From Index Procedure through 24 months of follow-up.
|
5.3%
7/132 • Number of events 7 • From Index Procedure through 24 months of follow-up.
|
|
Infections and infestations
Infection
|
23.2%
32/138 • Number of events 32 • From Index Procedure through 24 months of follow-up.
|
25.0%
33/132 • Number of events 33 • From Index Procedure through 24 months of follow-up.
|
|
Injury, poisoning and procedural complications
Pain
|
2.9%
4/138 • Number of events 4 • From Index Procedure through 24 months of follow-up.
|
1.5%
2/132 • Number of events 2 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Pseudoaneurysm
|
1.4%
2/138 • Number of events 2 • From Index Procedure through 24 months of follow-up.
|
0.76%
1/132 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Significant arm or hand edema
|
0.00%
0/138 • From Index Procedure through 24 months of follow-up.
|
0.76%
1/132 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Stenosis requiring intervention
|
3.6%
5/138 • Number of events 5 • From Index Procedure through 24 months of follow-up.
|
4.5%
6/132 • Number of events 6 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Thrombotic occlusion
|
9.4%
13/138 • Number of events 13 • From Index Procedure through 24 months of follow-up.
|
2.3%
3/132 • Number of events 3 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Other
|
50.0%
69/138 • Number of events 69 • From Index Procedure through 24 months of follow-up.
|
52.3%
69/132 • Number of events 69 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Perforation
|
0.72%
1/138 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
0.00%
0/132 • From Index Procedure through 24 months of follow-up.
|
Other adverse events
| Measure |
FLAIR
n=138 participants at risk
FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
|
PTA Only
n=132 participants at risk
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
|
|---|---|---|
|
Vascular disorders
Cerebrovascular Accident
|
0.00%
0/138 • From Index Procedure through 24 months of follow-up.
|
0.76%
1/132 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Congestive heart failure
|
2.9%
4/138 • Number of events 4 • From Index Procedure through 24 months of follow-up.
|
0.76%
1/132 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Embolism
|
0.72%
1/138 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
0.76%
1/132 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Hematoma
|
2.2%
3/138 • Number of events 3 • From Index Procedure through 24 months of follow-up.
|
0.76%
1/132 • Number of events 1 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Hemorrhage
|
6.5%
9/138 • Number of events 9 • From Index Procedure through 24 months of follow-up.
|
6.1%
8/132 • Number of events 8 • From Index Procedure through 24 months of follow-up.
|
|
Infections and infestations
Infection
|
7.2%
10/138 • Number of events 10 • From Index Procedure through 24 months of follow-up.
|
3.0%
4/132 • Number of events 4 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Pseudoaneurysm
|
5.1%
7/138 • Number of events 7 • From Index Procedure through 24 months of follow-up.
|
11.4%
15/132 • Number of events 15 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Significant arm or hand edema
|
2.2%
3/138 • Number of events 3 • From Index Procedure through 24 months of follow-up.
|
1.5%
2/132 • Number of events 2 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Steal syndrome
|
4.3%
6/138 • Number of events 6 • From Index Procedure through 24 months of follow-up.
|
2.3%
3/132 • Number of events 3 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Stenosis requiring intervention
|
59.4%
82/138 • Number of events 82 • From Index Procedure through 24 months of follow-up.
|
78.0%
103/132 • Number of events 103 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Thrombotic occlusion
|
34.1%
47/138 • Number of events 47 • From Index Procedure through 24 months of follow-up.
|
34.1%
45/132 • Number of events 45 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Vessel rupture
|
1.4%
2/138 • Number of events 2 • From Index Procedure through 24 months of follow-up.
|
1.5%
2/132 • Number of events 2 • From Index Procedure through 24 months of follow-up.
|
|
Vascular disorders
Other
|
9.4%
13/138 • Number of events 13 • From Index Procedure through 24 months of follow-up.
|
10.6%
14/132 • Number of events 14 • From Index Procedure through 24 months of follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60