Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Surgical Bypass Group Those patients that underwent bypass of blockage in the thigh with surgery. |
Procedure: 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. |
Procedure: Stent-graft placement
Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.
|
Outcome Measures
Primary Outcome Measures
- Primary artery/graft patency [48 months]
Secondary Outcome Measures
- Secondary artery/graft patency [48 months]
- Limb salvage [48 months]
- Improvement of lower extremity ischemic symptoms [48 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Symptomatic lower extremity ischemia patients treated by femoral-popliteal bypass or percutaneous covered stent graft in previous prospective study
Exclusion Criteria:
- NA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Vascular Associates | Dallas | Texas | United States | 75226 |
Sponsors and Collaborators
- Texas Vascular Associates
- W.L.Gore & Associates
Investigators
- Principal Investigator: Dennis R Gable, M.D., Texas Vascular Associates
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 009-198, Viabahn #2