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FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

RecruitingNAAges 18 Years - anyAllParacelsus Medical University
NCT06082466 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.

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📋 Eligibility rules (as published)
Inclusion Criteria * Age at least 18 years * Informed consent form with signature * Rutherford Category 3 (\<200m) or chronic critical ischemia (Rutherford Category 4-6) * Assured inflow and recipient artery. Exclusion Criteria * Pregnant or breastfeeding women * Active infection or sepsis * Acute ischemia * Endovascular procedure in the region to be treated. * Vein with outer diameter \<3.5 mm or \>8 mm under pressure. * Spliced Veins. * Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum). * Vasculitis * Coagulopathy * Radiation therapy near the anastomosis
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What it tests

  • FRAMED Infrainguinal Venous Bypass
  • Conventional Autologous Bypass
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Where

1 site
University Hospital of Salzburg, Paracelsus Medical University
Salzburg, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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