Status:
RECRUITING
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Lead Sponsor:
Paracelsus Medical University
Conditions:
Peripheral Arterial Occlusive Disease
Femoropopliteal Artery Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Patients presenting to Vascular Surgical Units are usually multimorbid with increased cardiopulmonary risk. Autologous venous bypass is indicated in certain situations despite the longer duration of s...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06082466
Start Date
September 11 2023
End Date
September 1 2027
Last Update
November 21 2023
Active Locations (1)
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1
University Hospital of Salzburg, Paracelsus Medical University
Salzburg, Austria, 5020