An interventional study of Femoral-popliteal Bypass and Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery in Atherosclerosis, Lower Extremity Ischemia and Claudication, sponsored by Texas Vascular Associates. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-09.
Sponsored by Texas Vascular Associates · Not applicable, Interventional, and Treatment
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.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 86 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Texas Vascular Associates is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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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.
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Femoral-popliteal surgical bypass with prosthetic graft
Procedure: Femoral-popliteal Bypass
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
Surgical placement of a prosthetic graft in the thigh from the groin to the knee
Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously
Also known as: Viabahn endoprosthesis
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 artery/graft patency
Time frame: 24 months
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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Texas Vascular Associates