Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease

Not Applicable

Completed

• Conditions: Atherosclerosis; Lower Extremity Ischemia; Claudication; Rest Pain
• Interventions: Procedure: Femoral-popliteal Bypass; Device: Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery

• Registration Number: NCT00693823
• Lead Sponsor: Texas Vascular Associates

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2007-05
• Study Completion: 2008-01
• Status Verified: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-06
• Last Update Submitted: 2008-06-06
• Study First Posted: 2008-06-09
• Last Update Posted: 2008-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Femoral-popliteal Bypass	Femoral-popliteal surgical bypass with prosthetic graft
2	Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery	Interventional angioplasty and placement of an ePTFE covered stent graft within the femoral-popliteal artery as an endoluminal bypass percutaneously

Primary Outcome Measures

Name	Time	Method
Primary artery/graft patency	24 months
Limb Salvage	24 months
Improvement in symptoms of lower extremity Ischemia	24 Months

Secondary Outcome Measures

Name	Time	Method
Secondary artery/graft patency	24 months

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States