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OpenTrials
Completed

NCT Number: NCT00693823

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Lower Extremity Ischemia Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Rest Pain Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Femoral-popliteal bypass

Procedure

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

Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery

Device

Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously

Other names: Viabahn endoprosthesis

Primary outcomes

  1. Primary artery/graft patency

    Time frame: 24 months

  2. Limb Salvage

    Time frame: 24 months

  3. Improvement in symptoms of lower extremity Ischemia

    Time frame: 24 Months

Secondary outcomes

  1. Secondary artery/graft patency

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Texas Vascular Associates

Other

Collaborators

  • W.L.Gore & Associates

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Jun 9, 2008
Registry last updated
Jun 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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