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| Name | Class |
|---|---|
| W.L.Gore & Associates | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Bypass Group | Those patients that underwent bypass of blockage in the thigh with surgery. |
| |
| Stent-graft group | Patients that underwent treatment of blockage in the thigh with balloon angioplasty and stent placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral-popliteal bypass | Procedure | Surgical bypass of blockage in the thigh |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary artery/graft patency | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary artery/graft patency | 48 months | |
| Limb salvage | 48 months | |
| Improvement of lower extremity ischemic symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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Vascular surgery clinic patients with ischemic symtpom of the lower extremities. Patients were previously enrolled in a randomized prospective study comparing treatment of blockage in the legs with a surgical bypass or percutaneous covered stent placemnt.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis R Gable, M.D. | Texas Vascular Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Vascular Associates | Dallas | Texas | 75226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17983772 | Background | 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. | |
| 16784314 | Background |
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| Stent-graft placement |
| Procedure |
Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement. |
|
| 48 months |
| 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. |
| 19028055 | Result | 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. |
| 17126520 | Result | 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. |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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