Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease
June 6, 2008 updated by: Texas Vascular Associates
A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75226
- Baylor University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
Femoral-popliteal surgical bypass with prosthetic graft
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Surgical placement of a prosthetic graft in the thigh from the groin to the knee
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|
ACTIVE_COMPARATOR: 2
Interventional angioplasty and placement of an ePTFE covered stent graft within the femoral-popliteal artery as an endoluminal bypass percutaneously
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Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary artery/graft patency
Time Frame: 24 months
|
24 months
|
|
Limb Salvage
Time Frame: 24 months
|
24 months
|
|
Improvement in symptoms of lower extremity Ischemia
Time Frame: 24 Months
|
24 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Secondary artery/graft patency
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology. 2000 Oct;217(1):95-104. doi: 10.1148/radiology.217.1.r00se0595.
- Hartung O, Otero A, Dubuc M, Boufi M, Barthelemy P, Aissi K, Alimi YS. Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants. Eur J Vasc Endovasc Surg. 2005 Sep;30(3):300-6. doi: 10.1016/j.ejvs.2005.04.027.
- Fischer M, Schwabe C, Schulte KL. Value of the hemobahn/viabahn endoprosthesis in the treatment of long chronic lesions of the superficial femoral artery: 6 years of experience. J Endovasc Ther. 2006 Jun;13(3):281-90. doi: 10.1583/05-1799.1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (ACTUAL)
May 1, 2007
Study Completion (ACTUAL)
January 1, 2008
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 6, 2008
First Posted (ESTIMATE)
June 9, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 9, 2008
Last Update Submitted That Met QC Criteria
June 6, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003-179, Viabahn #1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.