NCT02542267CompletedNot Applicable
Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
W.L.Gore & Associates41 sites in 4 countries108 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 41
- Primary Endpoint
- Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
Study Overview
Brief Summary
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient has a previously implanted (> 30 days) non-covered stent(s) located in the SFA
- •Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
- •Patient demonstrates an Ankle Brachial Index (ABI) <=0.
- •If ABI >0.9 or not measurable, patient is eligible for study if Toe Brachial Index is <=0.5
- •Patient has >=50% in-stent restenosis and / or an occlusion in a previously implanted (>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
- •Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
- •Patient has a reference vessel diameter between 4.0 and 6.5mm
- •Patient has at least one patent infrapopliteal runoff vessel (<50% stenosis) not requiring reintervention
- •Note: Additional Inclusion Criteria may apply
Exclusion Criteria
- •Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
- •Patient has a known intolerance to anticoagulation or antiplatelet therapy
- •Patient has known coagulation disorder, including hypercoagulability.
- •Patient has major distal amputation (above the transmetatarsal)
- •Patient has any previous surgery in the target vessel
- •Patient has had previous target vessel in-stent restenosis treated by relining with another stent
- •Patient has untreated flow-limiting aortoiliac stenotic disease
- •Note: Additional Exclusion Criteria may apply
Outcomes
Primary Outcomes
Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
Time Frame: 30 Days
Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure
Primary Effectiveness
Time Frame: 12 Months
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.
Secondary Outcomes
- Change in Ankle Brachial Index at 30 Days(Pre-procedure and 30 Days)
- Primary Patency at 30 Days and 12, 24, and 36 Months(30 days and 12, 24, and 36 months)
- Change in Rutherford Category at 30 Days(Pre-procedure and 30 Days)
- Number of Subjects With Acute Procedural Success(During hospitalization, approximately 1-2 days)
- Change in Rutherford Category at 2 Years(Pre-procedure and 2 Years)
- Change in Rutherford Category at 3 Years(Pre-procedure and 3 Years)
- Primary Assisted Patency at 30 Days and 12, 24, and 36 Months(30 days and 12, 24, and 36 months)
- Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months(30 days and 12, 24, and 36 months)
- Change in Ankle Brachial Index at 1 Year(Pre-procedure and 1 Year)
- Secondary Patency at 30 Days and 12, 24, and 36 Months(30 days and 12, 24, and 36 months)
- Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months(30 days and 12, 24, and 36 months)
- Change in Ankle Brachial Index at 2 Years(Pre-procedure and 2 Years)
- Change in Ankle Brachial Index at 3 Years(Pre-procedure and 3 Years)
- Change in Rutherford Category at 1 Year(Pre-procedure and 1 Year)
- Stent Fracture at 12, 24, and 36 Months(12, 24, and 36 months)
Investigators
Study Sites (41)
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