Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion
NCT ID: NCT00962897
Last Updated: 2009-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2003-09-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Surgical Bypass Group
Those patients that underwent bypass of blockage in the thigh with surgery.
Femoral-popliteal bypass
Surgical bypass of blockage in the thigh
Stent-graft group
Patients that underwent treatment of blockage in the thigh with balloon angioplasty and stent placement.
Stent-graft placement
Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.
Interventions
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Femoral-popliteal bypass
Surgical bypass of blockage in the thigh
Stent-graft placement
Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Texas Vascular Associates
OTHER
Responsible Party
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Texas Vascular Associates/Baylor University Medical Center
Principal Investigators
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Dennis R Gable, M.D.
Role: PRINCIPAL_INVESTIGATOR
Texas Vascular Associates
Locations
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Texas Vascular Associates
Dallas, Texas, United States
Countries
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References
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Alimi YS, Hakam Z, Hartung O, Boufi M, Barthelemy P, Aissi K, Dubuc M. Efficacy of Viabahn in the treatment of severe superficial femoral artery lesions: which factors influence long-term patency? Eur J Vasc Endovasc Surg. 2008 Mar;35(3):346-52. doi: 10.1016/j.ejvs.2007.09.005. Epub 2007 Nov 5.
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.
McQuade K, Gable D, Hohman S, Pearl G, Theune B. Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg. 2009 Jan;49(1):109-15, 116.e1-9; discussion 116. doi: 10.1016/j.jvs.2008.08.041. Epub 2008 Nov 22.
Kedora J, Hohmann S, Garrett W, Munschaur C, Theune B, Gable D. Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease. J Vasc Surg. 2007 Jan;45(1):10-6; discussion 16. doi: 10.1016/j.jvs.2006.08.074. Epub 2006 Nov 28.
Other Identifiers
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009-198, Viabahn #2
Identifier Type: -
Identifier Source: org_study_id
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