NCT06082466 FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
| NCT ID | NCT06082466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Paracelsus Medical University |
| Condition | Peripheral Arterial Occlusive Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-09-11 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Stephan Koter, MD, PD
PRINCIPAL INVESTIGATOR
Senior Physician
Frequently Asked Questions
Who can join the NCT06082466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Occlusive Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06082466 currently recruiting?
Yes, NCT06082466 is actively recruiting participants. Contact the research team at s.rassam@salk.at for enrollment information.
Where is the NCT06082466 trial being conducted?
This trial is being conducted at Salzburg, Austria.
Who is sponsoring the NCT06082466 clinical trial?
NCT06082466 is sponsored by Paracelsus Medical University. The principal investigator is Stephan Koter, MD, PD at Senior Physician. The trial plans to enroll 110 participants.