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NCT00300690 Clinical Trial

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

Critical Limb Ischemia Clinical Trial

Official title:
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft. Multicenter Randomized Study of an Impregnated Knitted Polyester Prosthesis Vs. PTFE (Uni-Graft Vs Gore-Tex).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00300690
Other study ID # C124
Secondary ID
Status Completed
Phase Phase 4
First received March 8, 2006
Last updated March 8, 2006
Start date October 1993
Est. completion date January 1999

Study information
Verified date March 2006
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date January 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• 6 mm Uni-graft® (B-Braun)

• 6 mm Gore-Tex® (WL Gore)

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen B. Braun Melsungen AG

Outcome
Type Measure Description Time frame Safety issue
Primary Primary uncorrected graft patency after 2 years
Secondary - Secondary graft patency after two years
Secondary - Limb survival after two years
Secondary - Complication rate perioperatively
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