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

Primary Purpose

Intermittent Claudication, Critical Limb Ischemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
6 mm Uni-graft® (B-Braun)
6 mm Gore-Tex® (WL Gore)
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Primary uncorrected graft patency after 2 years

    Secondary Outcome Measures

    - Secondary graft patency after two years
    - Limb survival after two years
    - Complication rate perioperatively

    Full Information

    First Posted
    March 8, 2006
    Last Updated
    March 8, 2006
    Sponsor
    University Hospital, Gentofte, Copenhagen
    Collaborators
    B. Braun Melsungen AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00300690
    Brief Title
    Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
    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).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1993 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 1999 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Gentofte, Copenhagen
    Collaborators
    B. Braun Melsungen AG

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intermittent Claudication, Critical Limb Ischemia
    Keywords
    Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    400 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    6 mm Uni-graft® (B-Braun)
    Intervention Type
    Device
    Intervention Name(s)
    6 mm Gore-Tex® (WL Gore)
    Primary Outcome Measure Information:
    Title
    Primary uncorrected graft patency after 2 years
    Secondary Outcome Measure Information:
    Title
    - Secondary graft patency after two years
    Title
    - Limb survival after two years
    Title
    - Complication rate perioperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Torben V Schroeder, Professor
    Organizational Affiliation
    Rigshospitalet, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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