FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Launched by PARACELSUS MEDICAL UNIVERSITY · Oct 9, 2023

Keywords

ClinConnect Summary

The FRAMED trial is studying two types of surgical procedures for patients with serious leg circulation problems, specifically those with conditions like Peripheral Arterial Occlusive Disease and critical limb-threatening ischemia. The researchers want to understand how well a specific type of vein used in surgery (called a covered venous conduit) works compared to a standard vein (autologous vein) when performing bypass surgery below the knee. This is important because better options for surgery can lead to improved blood flow and help patients avoid serious complications related to their condition.

To participate in this trial, individuals must be at least 18 years old and have serious circulation issues, such as not being able to walk more than 200 meters without pain. However, some people may not be eligible, including pregnant or breastfeeding women, those with active infections, or certain blood disorders. If you join the study, you can expect to have regular check-ups and tests to monitor your health after the surgery. This research aims to provide valuable information that could help many patients in the future.

Gender

ALL

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