Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)

Phase 4

Completed

• Conditions: Intermittent Claudication; Critical Limb Ischemia

• Registration Number: NCT00300690
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.

Detailed Description

Objective: To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft

Study Timeline

• Study Start: 1993-10
• Study Completion: 1999-01
• Status Verified: 2006-03
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Last Update Submitted: 2006-03-08
• Study First Posted: 2006-03-09
• Last Update Posted: 2006-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.

Exclusion Criteria

• pregnancy
• No consent to participate in the study
• Previous enrollment in the study
• follow-up is not possible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary uncorrected graft patency after 2 years

Secondary Outcome Measures

Name	Time	Method
- Secondary graft patency after two years
- Limb survival after two years
- Complication rate perioperatively