This study is testing a device called the LimFlow Stent Graft System for people with late-stage chronic limb-threatening ischemia (CLTI), a severe form of peripheral arterial disease where blood flow to the leg is very poor. The LimFlow System creates a new connection between an artery and a vein in the leg to improve blood flow when other treatments aren't possible. We want to see if this system can help prevent amputation. You might be able to join if you are between 18 and 95 years old and have a diagnosis of CLTI, specifically Rutherford Classification 5 (meaning you have an ischemic ulcer) or other severe symptoms. The main goal is to see how many people are alive and haven't had an amputation after 6 months. The study is currently recruiting participants.

Study design

This is a single-arm study, meaning all participants will receive the LimFlow Stent Graft System. It plans to enroll 100 participants.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for at least 6 months to assess amputation-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.