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Clinical Trials/NCT00300690
NCT00300690
Completed
Phase 4

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).

University Hospital, Gentofte, Copenhagen0 sites400 target enrollmentOctober 1993
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ConditionsIntermittent ClaudicationCritical Limb Ischemia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Intermittent Claudication
Sponsor
University Hospital, Gentofte, Copenhagen
Enrollment
400
Primary Endpoint
Primary uncorrected graft patency after 2 years
Status
Completed
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
October 1993
End Date
January 1999
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Gentofte, Copenhagen

Eligibility Criteria

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

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