Atherosclerosis Clinical Trial
Official title:
A Retrospective Review of Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion With Four Years Followup
Verified date | August 2009 |
Source | Texas Vascular Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 2009 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Symptomatic lower extremity ischemia patients treated by femoral-popliteal bypass or percutaneous covered stent graft in previous prospective study Exclusion Criteria: |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Texas Vascular Associates | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Vascular Associates | W.L.Gore & Associates |
United States,
Alimi YS, Hakam Z, Hartung O, Boufi M, Barthèlemy 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. Epub 2007 Nov 5. — View Citation
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. — View Citation
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( — View Citation
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, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary artery/graft patency | 48 months | No | |
Secondary | Secondary artery/graft patency | 48 months | No | |
Secondary | Limb salvage | 48 months | No | |
Secondary | Improvement of lower extremity ischemic symptoms | 48 months | No |
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