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

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Critical Limb Ischemia; Intermittent Claudication

Treatments: Device: 6 mm Gore-Tex® (WL Gore); Device: 6 mm Uni-graft® (B-Braun)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00300690

C124

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind