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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-10-31

Study Completion Date

1999-01-31

Brief Summary

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

Detailed Description

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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

Conditions

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Intermittent Claudication Critical Limb Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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6 mm Uni-graft® (B-Braun)

Intervention Type DEVICE

6 mm Gore-Tex® (WL Gore)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Torben V Schroeder, Professor

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Other Identifiers

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C124

Identifier Type: -

Identifier Source: org_study_id