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

Sponsor

Texas Vascular Associates (Other)

Overall Status

Completed

CT.gov ID

NCT00693823

Collaborator

W.L.Gore & Associates (Industry)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Lower Extremity Ischemia Claudication Rest Pain	Procedure: Femoral-popliteal Bypass Device: Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Femoral-popliteal surgical bypass with prosthetic graft	Procedure: Femoral-popliteal Bypass Surgical placement of a prosthetic graft in the thigh from the groin to the knee
Active Comparator: 2 Interventional angioplasty and placement of an ePTFE covered stent graft within the femoral-popliteal artery as an endoluminal bypass percutaneously	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 Other Names: Viabahn endoprosthesis

Arm

Intervention/Treatment

Active Comparator: 1

Femoral-popliteal surgical bypass with prosthetic graft

Procedure: Femoral-popliteal Bypass

Surgical placement of a prosthetic graft in the thigh from the groin to the knee

Active Comparator: 2

Interventional angioplasty and placement of an ePTFE covered stent graft within the femoral-popliteal artery as an endoluminal bypass percutaneously

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

Other Names:

Viabahn endoprosthesis

Outcome Measures

Primary Outcome Measures

Primary artery/graft patency [24 months]
Limb Salvage [24 months]
Improvement in symptoms of lower extremity Ischemia [24 Months]

Secondary Outcome Measures

Secondary artery/graft patency [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.