Evaluating Safety and Effectiveness of Percutaneous Deep Foot Venous Arterialization in Patients with No-Option Chronic Limb-Threatening Ischemia

What this Trial Is About

This research aims to assess the early safety and effectiveness of a procedure called percutaneous deep foot venous arterialization in patients with chronic limb-threatening ischemia CLTI who have no other revascularization options. CLTI is the most advanced stage of lower limb arterial disease, carrying high risks of death and major amputation. About 5-10% of patients with peripheral arterial disease develop CLTI, which has a 20% mortality rate within six months of diagnosis. For some patients, standard revascularization methods are not possible or effective, and this study explores an alternative approach to restore blood flow. The study is a multicenter, prospective, single-arm observational study including patients undergoing the PiPER procedure, which involves using veins to reroute arterial blood flow to the foot instead of damaged arteries. The procedure will follow current clinical practice without extra tests or procedures. Patients will be monitored through clinic visits at 30 days, 6 months, 12 months, and 24 months after the procedure to track their progress. Participants will be involved in scheduled follow-up visits where researchers will collect data on their demographics, medical history, treatment details, and health outcomes for up to two years. Assessments will include safety outcomes at 30 days and 6 months, procedural success, blood vessel openness, amputation rates, wound size, oxygen levels in tissues, and disease severity classifications at several intervals. This long-term monitoring aims to evaluate the procedures safety and effectiveness in this high-risk patient group.

Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia