Comparing two types of venous bypass for leg artery issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of two different types of venous bypass surgeries for patients with peripheral arterial occlusive disease. Participants will be randomly assigned to receive either a plain autologous venous conduit or a covered venous conduit. The study will monitor the patency of these conduits over time, with follow-ups scheduled at 6 weeks, 3 months, 6 months, 12 months, and 2 years post-surgery. The goal is to determine if the covered conduit can reduce complications related to intimal hyperplasia compared to the standard approach.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital of Salzburg, Paracelsus Medical University
  Salzburg, Austria Recruiting

Study contacts

• Principal investigator: Stephan Koter, MD, PD — Senior Physician
• Study coordinator: Stephanie Rassam, MD
• Email: s.rassam@salk.at
• Phone: +43 572550 57506

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.