A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Texas Vascular Associates
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Primary artery/graft patency
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients that had atherosclerotic stenotic or occlusive lesions of the superficial femoral artery with no significant aorto-iliac disease. The infra-popliteal segment had to be patent with at least single vessel run-off to the ankle. Patients had to be acceptable surgical candidates in the event they were randomized to the surgical arm.
Exclusion Criteria
- •Non-operative candidate,Contraindication to IV contrast use, Planned surgery with venous conduit, previously stented segment of the superficial femoral artery, poorly compliant patient.
Outcomes
Primary Outcomes
Primary artery/graft patency
Time Frame: 24 months
Limb Salvage
Time Frame: 24 months
Improvement in symptoms of lower extremity Ischemia
Time Frame: 24 Months
Secondary Outcomes
- Secondary artery/graft patency(24 months)