Trial Outcomes & Findings for In-Stent Restenosis Post-Approval Study (NCT NCT02542267)
NCT ID: NCT02542267
Last Updated: 2023-10-16
Results Overview
Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.
COMPLETED
NA
108 participants
12 Months
2023-10-16
Participant Flow
Participant milestones
| Measure |
Gore VIABAHN Endoprosthesis
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
Gore VIABAHN Endoprosthesis
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Death
|
13
|
|
Overall Study
Surgical Bypass of All Study Devices
|
13
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
Race only collected among U.S. study subjects.
Baseline characteristics by cohort
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Age, Continuous
|
70.7 Years
STANDARD_DEVIATION 10.1 • n=108 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=86 Participants • Race only collected among U.S. study subjects.
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=86 Participants • Race only collected among U.S. study subjects.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=86 Participants • Race only collected among U.S. study subjects.
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=86 Participants • Race only collected among U.S. study subjects.
|
|
Race (NIH/OMB)
White
|
67 Participants
n=86 Participants • Race only collected among U.S. study subjects.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=86 Participants • Race only collected among U.S. study subjects.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=86 Participants • Race only collected among U.S. study subjects.
|
|
Region of Enrollment
United States
|
86 participants
n=108 Participants
|
|
Region of Enrollment
Germany
|
19 participants
n=108 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=108 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=108 Participants
|
|
Rutherford Category
Category 0
|
0 Participants
n=108 Participants
|
|
Rutherford Category
Category 1
|
0 Participants
n=108 Participants
|
|
Rutherford Category
Category 2
|
10 Participants
n=108 Participants
|
|
Rutherford Category
Category 3
|
84 Participants
n=108 Participants
|
|
Rutherford Category
Category 4
|
3 Participants
n=108 Participants
|
|
Rutherford Category
Category 5
|
11 Participants
n=108 Participants
|
|
Rutherford Category
Category 6
|
0 Participants
n=108 Participants
|
|
Ankle Brachial Index (ABI)
|
0.670 Ratio
STANDARD_DEVIATION 0.177 • n=92 Participants • Data missing or unknown/not measured.
|
PRIMARY outcome
Timeframe: 12 MonthsPrimary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Primary Effectiveness
|
0.715 Probability
Interval 0.607 to 0.797
|
PRIMARY outcome
Timeframe: 30 DaysPrimary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
|
105 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, approximately 1-2 daysAcute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Number of Subjects With Acute Procedural Success
|
107 Participants
|
SECONDARY outcome
Timeframe: 30 days and 12, 24, and 36 monthsPrimary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Primary Patency at 30 Days and 12, 24, and 36 Months
30 Day
|
0.99 Probability
Interval 0.932 to 0.999
|
|
Primary Patency at 30 Days and 12, 24, and 36 Months
12 Month
|
0.715 Probability
Interval 0.607 to 0.797
|
|
Primary Patency at 30 Days and 12, 24, and 36 Months
24 Month
|
0.561 Probability
Interval 0.448 to 0.661
|
|
Primary Patency at 30 Days and 12, 24, and 36 Months
36 Month
|
0.449 Probability
Interval 0.333 to 0.558
|
SECONDARY outcome
Timeframe: 30 days and 12, 24, and 36 monthsPrimary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
30 Day
|
1.00 Probability
Interval 1.0 to 1.0
|
|
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
12 Month
|
0.772 Probability
Interval 0.669 to 0.846
|
|
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
24 Month
|
0.643 Probability
Interval 0.529 to 0.736
|
|
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
36 Month
|
0.556 Probability
Interval 0.434 to 0.662
|
SECONDARY outcome
Timeframe: 30 days and 12, 24, and 36 monthsSecondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Secondary Patency at 30 Days and 12, 24, and 36 Months
24 Month
|
0.822 Probability
Interval 0.718 to 0.891
|
|
Secondary Patency at 30 Days and 12, 24, and 36 Months
36 Month
|
0.732 Probability
Interval 0.608 to 0.822
|
|
Secondary Patency at 30 Days and 12, 24, and 36 Months
30 Day
|
1.00 Probability
Interval 1.0 to 1.0
|
|
Secondary Patency at 30 Days and 12, 24, and 36 Months
12 Month
|
0.929 Probability
Interval 0.849 to 0.967
|
SECONDARY outcome
Timeframe: 30 days and 12, 24, and 36 monthsTarget Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
36 Month
|
0.668 Probability
Interval 0.558 to 0.756
|
|
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
30 Day
|
1.00 Probability
Interval 1.0 to 1.0
|
|
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
12 Month
|
0.828 Probability
Interval 0.738 to 0.89
|
|
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
24 Month
|
0.746 Probability
Interval 0.645 to 0.823
|
SECONDARY outcome
Timeframe: 30 days and 12, 24, and 36 monthsMajor Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
30 Day
|
1.00 Probability
Interval 1.0 to 1.0
|
|
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
12 Month
|
1.00 Probability
Interval 1.0 to 1.0
|
|
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
24 Month
|
1.00 Probability
Interval 1.0 to 1.0
|
|
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
36 Month
|
1.00 Probability
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Pre-procedure and 30 DaysPopulation: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 30 days.
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=82 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Ankle Brachial Index at 30 Days
Pre-procedure
|
0.679 ratio
Standard Deviation 0.176
|
|
Change in Ankle Brachial Index at 30 Days
30 Days
|
1.004 ratio
Standard Deviation 0.133
|
|
Change in Ankle Brachial Index at 30 Days
Change at 30 Days
|
0.325 ratio
Standard Deviation 0.205
|
SECONDARY outcome
Timeframe: Pre-procedure and 1 YearPopulation: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 1 year.
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=66 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Ankle Brachial Index at 1 Year
1 Year
|
0.921 ratio
Standard Deviation 0.188
|
|
Change in Ankle Brachial Index at 1 Year
Change at 1 Year
|
0.229 ratio
Standard Deviation 0.235
|
|
Change in Ankle Brachial Index at 1 Year
Pre-procedure
|
0.693 ratio
Standard Deviation 0.164
|
SECONDARY outcome
Timeframe: Pre-procedure and 2 YearsPopulation: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 2 Years.
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=54 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Ankle Brachial Index at 2 Years
Pre-procedure
|
0.700 ratio
Standard Deviation 0.159
|
|
Change in Ankle Brachial Index at 2 Years
2 Years
|
0.913 ratio
Standard Deviation 0.187
|
|
Change in Ankle Brachial Index at 2 Years
Change at 2 Years
|
0.213 ratio
Standard Deviation 0.227
|
SECONDARY outcome
Timeframe: Pre-procedure and 3 YearsPopulation: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 3 Years.
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=47 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Ankle Brachial Index at 3 Years
Pre-procedure
|
0.708 ratio
Standard Deviation 0.162
|
|
Change in Ankle Brachial Index at 3 Years
3 Years
|
0.937 ratio
Standard Deviation 0.174
|
|
Change in Ankle Brachial Index at 3 Years
Change at 3 Years
|
0.229 ratio
Standard Deviation 0.231
|
SECONDARY outcome
Timeframe: Pre-procedure and 30 DaysPopulation: Includes all subjects with Rutherford Category measured at both pre-procedure and 30 days.
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=101 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Rutherford Category at 30 Days
Pre-procedure
|
3.2 units on a scale
Standard Deviation 0.7
|
|
Change in Rutherford Category at 30 Days
30 Days
|
0.6 units on a scale
Standard Deviation 1.2
|
|
Change in Rutherford Category at 30 Days
Change at 30 Days
|
-2.5 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Pre-procedure and 1 YearPopulation: Includes all subjects with Rutherford Category measured at both pre-procedure and 1 year.
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=77 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Rutherford Category at 1 Year
Pre-procedure
|
3.0 units on a scale
Standard Deviation 0.6
|
|
Change in Rutherford Category at 1 Year
1 Year
|
0.8 units on a scale
Standard Deviation 1.1
|
|
Change in Rutherford Category at 1 Year
Change at 1 Year
|
-2.2 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Pre-procedure and 2 YearsPopulation: Includes all subjects with Rutherford Category measured at both pre-procedure and 2 years.
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=59 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Rutherford Category at 2 Years
Pre-procedure
|
3.1 units on a scale
Standard Deviation 0.6
|
|
Change in Rutherford Category at 2 Years
1 Year
|
0.6 units on a scale
Standard Deviation 1.1
|
|
Change in Rutherford Category at 2 Years
Change at 2 Years
|
-2.4 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Pre-procedure and 3 YearsPopulation: Includes all subjects with Rutherford Category measured at both pre-procedure and 3 years.
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=52 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Change in Rutherford Category at 3 Years
Pre-procedure
|
3.0 units on a scale
Standard Deviation 0.6
|
|
Change in Rutherford Category at 3 Years
1 Year
|
0.8 units on a scale
Standard Deviation 1.2
|
|
Change in Rutherford Category at 3 Years
Change at 3 Years
|
-2.3 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: Includes all subjects who had x-ray or angiographic data to determine device stent fracture at the reported corresponding follow-up time period..
Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images.
Outcome measures
| Measure |
Gore VIABAHN Endoprosthesis
n=108 Participants
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Stent Fracture at 12, 24, and 36 Months
24 Month
|
0 Participants
|
|
Stent Fracture at 12, 24, and 36 Months
36 Month
|
0 Participants
|
|
Stent Fracture at 12, 24, and 36 Months
12 Month
|
0 Participants
|
Adverse Events
Gore VIABAHN Endoprosthesis
Serious adverse events
| Measure |
Gore VIABAHN Endoprosthesis
n=108 participants at risk
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
1.9%
2/108 • Number of events 4 • 36 months
|
|
Cardiac disorders
Atrial flutter
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Cardiac disorders
Atrioventricular junctional escape rhythm
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Cardiac disorders
Bradycardia
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Cardiac disorders
Chest pain - cardiac
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Cardiac disorders
Congestive heart failure
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Cardiac disorders
Decompensation cardiac
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
3.7%
4/108 • Number of events 5 • 36 months
|
|
Cardiac disorders
Non STEMI
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Cardiac disorders
Sick sinus syndrome
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Cardiac disorders
Triple vessel disease
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Cardiac disorders
Unstable angina
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
Colon stenosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Lower gastrointestinal bleeding
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Retroperitoneal bleed
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Delayed healing of wound
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
In-stent arterial restenosis
|
5.6%
6/108 • Number of events 6 • 36 months
|
|
General disorders
In-stent arterial stenosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Systemic inflammatory response syndrome
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
General disorders
Unknown cause of death
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Vessel puncture site hematoma
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
General disorders
Weakness
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
General disorders
Wound healing delayed
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Bile duct stricture
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Biliary colic
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Bilateral pneumonia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Cellulitis genital organ (male)
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Cellulitis of leg
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Febrile infection
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Gangrene peripheral
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Infectious diarrhea
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Influenza A virus infection
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Influenza B virus infection
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Lobar pneumonia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Osteomyelitis of the foot
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Infections and infestations
Pneumonia
|
4.6%
5/108 • Number of events 7 • 36 months
|
|
Infections and infestations
Sepsis
|
4.6%
5/108 • Number of events 8 • 36 months
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Injury, poisoning and procedural complications
Broken bones
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Drug overdose accidental
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Injury, poisoning and procedural complications
Fractured hip
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of hypopharynx
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urothelial carcinoma urethra
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Carotid artery disease
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Cerebral infarct
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Cerebral infarction
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Nervous system disorders
Grand mal seizure
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Hemiparesis (left)
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Internal carotid artery stenosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Ischemic stroke
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Near syncope
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Seizures
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Stroke
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Syncope
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Transient ischemic attack
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Tremor aggravated
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Product Issues
Device occlusion
|
16.7%
18/108 • Number of events 22 • 36 months
|
|
Product Issues
Thrombosis in device
|
4.6%
5/108 • Number of events 6 • 36 months
|
|
Psychiatric disorders
Mental status changes
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Renal and urinary disorders
Acute kidney failure
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Acute retention of urine
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic respiratory failure
|
2.8%
3/108 • Number of events 4 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary necrotizing granuloma
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Skin and subcutaneous tissue disorders
Foot ulcer
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Acute limb ischemia
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Vascular disorders
Aortic stenosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Atherosclerosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Critical limb ischemia
|
0.93%
1/108 • Number of events 4 • 36 months
|
|
Vascular disorders
Hypertensive crisis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Hypertensive emergency
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Hypotension
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Vascular disorders
Malignant hypertension
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.93%
1/108 • Number of events 2 • 36 months
|
Other adverse events
| Measure |
Gore VIABAHN Endoprosthesis
n=108 participants at risk
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
|
|---|---|
|
General disorders
In-stent arterial restenosis
|
13.0%
14/108 • Number of events 20 • 36 months
|
|
Product Issues
Device occlusion
|
11.1%
12/108 • Number of events 12 • 36 months
|
|
Vascular disorders
Arterial stenosis
|
7.4%
8/108 • Number of events 8 • 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator agree not to submit any Publication until Study Completion and the multi-center Publication has been published. If the multi-center Publication has not been submitted within 12 months of Study Completion, Institution and Investigator may be able to proceed with submission of the Publication.
- Publication restrictions are in place
Restriction type: OTHER