Treatment of Late-Stage Chronic Limb-Threatening Ischemia Using the LimFlow System A Minimally Invasive Procedure to Arterialize Pedal Veins in Patients Unsuitable for Conventional Limb Salvage

What this Trial Is About

This research aims to provide additional information on the LimFlow System for treating late-stage chronic limb-threatening ischemia in patients who cannot have standard endovascular or surgical limb salvage procedures. The study focuses on using a minimally invasive approach to create an arteriovenous connection in the below-the-knee blood vessels to arterialize the pedal veins and improve blood flow in the affected limb. Participants will be treated with the LimFlow Stent Graft System, which creates an arteriovenous fistula in the target limb through a percutaneous, endovascular procedure. This single-arm, multi-center study involves one treatment group receiving this device to assess its use and effects in this patient population. During the study, participants will undergo assessments including wound healing evaluations, limb salvage status, and patency of the treated vessels at multiple time points up to 12 months. Researchers will monitor amputation-free survival at 6 months as the primary outcome and assess other clinical and procedural outcomes such as technical success, wound size reduction, and safety measures. Participants will be followed for ongoing evaluation of treatment impact and safety.

PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia