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

University Hospital, Gentofte, Copenhagen400 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Intermittent Claudication Critical Limb Ischemia

Interventions

6 mm Uni-graft® (B-Braun)DEVICE

6 mm Gore-Tex® (WL Gore)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary uncorrected graft patency after 2 years

Secondary Outcomes

- Secondary graft patency after two years

- Limb survival after two years

- Complication rate perioperatively

Data from ClinicalTrials.gov

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