Clinical trial NCT00962897: Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lower Extremity Ischemia
Claudication
Rest Pain
Keywords: atherosclerosis
covered stent
percutaneous intervention
stent
angioplasty
Lead sponsor: Texas Vascular Associates
Sponsor class: OTHER
Collaborators: name: W.L.Gore & Associates
First posted: 2009-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Primary artery/graft patency
timeFrame: 48 months
Secondary outcomes:
measure: Secondary artery/graft patency
timeFrame: 48 months
measure: Limb salvage
timeFrame: 48 months
measure: Improvement of lower extremity ischemic symptoms
timeFrame: 48 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Vascular Associates
state: Texas
Study officials:
affiliation: Texas Vascular Associates
name: Dennis R Gable, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1583/05-1799.1.
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, 116.e1-9; discussion 116. doi: 10.1016/j.jvs.2008.08.041. Epub 2008 Nov 22.
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(1):10-6; discussion 16. doi: 10.1016/j.jvs.2006.08.074. Epub 2006 Nov 28.