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

The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational device, the LimFlow Stent Graft System, designed to create a connection between the artery and vein in the Below-The-Knee (BTK) vascular system. This procedure is intended to restore blood flow to the foot and is only for patients with “chronic limb-threatening ischemia” that are not likely to be helped with standard operations or procedures. The LimFlow System is available only as an experimental device as a part of this clinical trial, and cannot be provided unless you agree to participate in the research.