Comparing two types of venous bypass for leg artery issues
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
NA · Paracelsus Medical University · NCT06082466
This study is testing whether a special type of vein surgery can help people with leg artery problems do better than a standard vein surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Paracelsus Medical University (other) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Salzburg) |
| Trial ID | NCT06082466 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Rutherford Category 3 or chronic critical ischemia.
Not a fit: Patients with active infections, acute ischemia, or certain vascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and longer-lasting results for patients undergoing venous bypass surgery.
How similar studies have performed: Previous studies have suggested that using covered conduits may improve outcomes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salzburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia, Claudication, Intermittent, Extraluminal Bypass Stenting, Autologous Vein Graft, Bypass Extremity Graft