NCT00693823

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

A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Texas Vascular Associates · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Lower Extremity Ischemia
• Claudication
• Rest Pain

Interventions

Type	Name	Description
PROCEDURE	Femoral-popliteal Bypass	Surgical placement of a prosthetic graft in the thigh from the groin to the knee
DEVICE	Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery	Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously

Timeline

• Start date: 2003-09-01
• Primary completion: 2007-05-01
• Completion: 2008-01-01
• First posted: 2008-06-09
• Last updated: 2008-06-09

Locations

1 site across 1 country: United States