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Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein

Study acronym: REVA
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study sites: 0 to 1

    Study Identification, Study Status, Contacts/Locations, Referencesv7

  2. Minor

    Study Status, Sponsor/Collaborators, Study Design

    Re-verified, no change to tracked fields

    v6

  3. Minor

    Trial status: Active, Not Recruiting to Completed

    Primary and study completion dates changed from estimate of Dec 2010 to May 2011

    Study Statusv5

  4. Minor

    Study sites: 1 to 0

    Primary completion date: Dec 2010; Interventions: femoropopliteal artery bypass (Device) to femoropopliteal artery bypass (Device), femoropopliteal artery bypass (Device); Secondary endpoints revised (5); and 1 more

    Show all 5 changes in this update
    • Minor Study sites: 1 to 0
    • Minor Primary completion date: Dec 2010
    • Minor Interventions: femoropopliteal artery bypass (Device) to femoropopliteal artery bypass (Device), femoropopliteal artery bypass (Device)
    • Minor Secondary endpoints revised (5)
      Show what changed
      primaryPrimary and secondary permeability
    • Minor Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv4

  5. Minor

    Completion date: Dec 2010

    Study Identification, Study Status, Oversight, Study Design, Outcome Measuresv3

  6. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Secondary endpoints revised (5); Site details revised

    Show what changed: Secondary endpoints
    - Mortality - Morbidity - permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter) - primary and secondary permeability - leg salvage

    Study Status, Outcome Measures, Contacts/Locationsv2

  7. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have not been compared regarding bypass permeability and limb salvage. Thus, this study will compare the permeability rate of above knee femoro popliteal surgery whether performed with autologous vein versus prosthesis
Trial Details
NCT Number NCT00221715
Lead Sponsor University Hospital, Bordeaux
Collaborators: Ministry of Health, France
Conditions Arteritis, Diabetes
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov