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

NCT00962897 | Completed DMC

• 1 other identifier: 009-198, Viabahn #2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Lower Extremity Ischemia; Claudication; Rest Pain

Keywords

atherosclerosis; covered stent; percutaneous intervention; stent; angioplasty

Outcome Measures

Primary Outcomes (1)

• Primary artery/graft patency

  48 months

Secondary Outcomes (3)

• Secondary artery/graft patency

  48 months

• Limb salvage

  48 months

• Improvement of lower extremity ischemic symptoms

  48 months

Study Arms (2)

Surgical Bypass Group

Those patients that underwent bypass of blockage in the thigh with surgery.

Procedure: Femoral-popliteal bypass

Stent-graft group

Patients that underwent treatment of blockage in the thigh with balloon angioplasty and stent placement.

Procedure: Stent-graft placement

Interventions

Femoral-popliteal bypass PROCEDURE

Surgical bypass of blockage in the thigh

Surgical Bypass Group

Stent-graft placement PROCEDURE

Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.

Stent-graft group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Symptomatic lower extremity ischemia patients treated by femoral-popliteal bypass or percutaneous covered stent graft in previous prospective study

Sponsors & Collaborators

• Texas Vascular Associates: lead
• W.L.Gore & Associates: collaborator

Study Sites (1)

Texas Vascular Associates

Dallas, Texas, 75226, United States

Location

Related Publications (4)

• 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.

  PMID: 17983772 BACKGROUND

• 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.

  PMID: 16784314 BACKGROUND

• 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.

  PMID: 19028055 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.

  PMID: 17126520 RESULT

MeSH Terms

Conditions

Atherosclerosis; Intermittent Claudication

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis R Gable, M.D.

  Texas Vascular Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: September 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: July 1, 2009
• Last Updated: August 20, 2009

Record last verified: 2009-08

Locations

US (1)