HVP_ISR 14-04

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 GOREĀ® VIABAHNĀ® 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
N/A
NCT02542267
Heart and Vascular, All Other
Peripheral Artery Disease
Ethan Korngold MD
W.L. Gore and Associates, Inc.
Ellen Muir
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center