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RecruitingNot ApplicableNCT06082466

FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Sponsor

Paracelsus Medical University

Enrollment

110 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Peripheral arterial occlusive diseaseFemoropopliteal StenosisClaudication, IntermittentCritical Limb-Threatening IschemiaFemoropopliteal Artery Occlusion

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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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Interventions

PROCEDUREFRAMED Infrainguinal Venous Bypass

The harvested vein graft will be covered with a mesh.

PROCEDUREConventional Autologous Bypass

The harvested vein graft will be used without a mesh coating.

Locations(1)

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, Austria

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NCT06082466

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