Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for Treatment of In-Stent Restenosis in the Superficial Femoral Artery
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.
Key Inclusion Criteria:
1. Patient is 18 years or older and has a previously implanted (>30 days) non-covered stent(s) located in the superficial femoral artery
2. Patient has life-style limiting claudication, resting leg pain or minor tissue loss
(Rutherford Category 2-5)
3. Patient demonstrates an ABI less than or equal to 0.9. If ABI > 0.9 or not measureable, patient is eligible for study if toe-brachial index (TBI) is less than or equal to 0.5
Angiographic inclusion criteria must be met as well.
See clinicaltrials.gov for full details
Heart and Vascular,
Peripheral Artery Disease
Ethan Korngold MD
W.L. Gore and Associates, Inc.
- Providence Portland Medical Center
- Providence St. Vincent Medical Center