Comparison of Mesh Covered Versus Conventional Autologous Vein Bypass Surgery for Peripheral Arterial Disease and Critical Limb Ischemia

What this Trial Is About

Researchers are evaluating the success of patency after autologous infrainguinal bypass surgery in patients with peripheral arterial occlusive disease and related conditions. The trial compares two surgical approaches a traditional venous conduit versus a venous conduit covered with a mesh. The goal is to see if covering the harvested vein can reduce complications like intimal hyperplasia, which has been shown to affect the longevity of the bypass. Participants will be randomly assigned to either receive a conventional autologous bypass where the vein graft is used without a mesh, or the FRAMED infrainguinal venous bypass where the harvested vein graft is covered with a mesh. The study is conducted at a university hospital vascular surgery division. Follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 2 years after surgery to monitor the outcomes. During the trial, participants will undergo regular assessments to evaluate the primary measure of vein graft patency over two years. Secondary outcomes include procedure-related mortality within two years, mortality within 30 days, and limb salvage rates after the procedure. Participants will be monitored closely during these follow-ups to track the success and safety of the surgical methods over time.

FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial