RecruitingNot Applicable

FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Austria110 participantsStarted 2023-09-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of primary patency of the venous bypass

Timeframe: 2 years

Trial details

NCT IDNCT06082466

SponsorParacelsus Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

Contact for this trial

Stephanie Rassam, MD

+43 572550 57506 s.rassam@salk.at

View on ClinicalTrials.gov More Peripheral Arterial Occlusive Disease trials