FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Trial Parameters
Brief 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.
Eligibility Criteria
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