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.
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.
Pregnant or breastfeeding women
Active infection or sepsis
Acute ischemia
Endovascular procedure in the region to be treated.
Parallel
FRAMED Infrainguinal Venous Bypass
Procedure/SurgeryThe harvested vein graft will be covered with a mesh.
Conventional Autologous Bypass
Procedure/SurgeryThe harvested vein graft will be used without a mesh coating.
Incidence of primary patency of the venous bypass
The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.
Incidence of procedure-related mortality
Mortality intervention-related
Incidence of 30-day mortality
Number of participants, who die within 30 days after the procedure.
Incidence of limb salvage after procedure
Amputation free survival
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