Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962897
• Other study ID #: 009-198, Viabahn #2
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: August 19, 2009
• Start date: September 2003
• Est. completion date: July 2009

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atherosclerosis
• Claudication
• Lower Extremity Ischemia
• Rest Pain

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Texas Vascular Associates	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Vascular Associates	W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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