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

Completed

• Conditions: Lower Extremity Ischemia; Claudication; Atherosclerosis; Rest Pain
• Interventions: Procedure: Femoral-popliteal bypass; Procedure: Stent-graft placement

• Registration Number: NCT00962897
• Lead Sponsor: Texas Vascular Associates

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2007-05
• Study Completion: 2009-07
• Status Verified: 2009-08
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Last Update Submitted: 2009-08-19
• Study First Posted: 2009-08-20
• Last Update Posted: 2009-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical Bypass Group	Femoral-popliteal bypass	Those patients that underwent bypass of blockage in the thigh with surgery.
Stent-graft group	Stent-graft placement	Patients that underwent treatment of blockage in the thigh with balloon angioplasty and stent placement.

Primary Outcome Measures

Name	Time	Method
Primary artery/graft patency	48 months

Secondary Outcome Measures

Name	Time	Method
Improvement of lower extremity ischemic symptoms	48 months
Secondary artery/graft patency	48 months
Limb salvage	48 months

Trial Locations

Locations (1)

Texas Vascular Associates; 🇺🇸 Dallas, Texas, United States