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

Clinical Trial Details

The LimFlow™ System, PMA P220025, received U.S. Food and Drug Administration (FDA) approval on September 11, 2023. The purpose of this post-approval study is to provide additional information on a device designed to create a connection between the artery and vein in the Below The Knee (BTK) vascular system, using a minimally invasive approach. This procedure is only indicated for patients with “chronic limb-threatening ischemia” who are not likely to be helped with standard operations or procedures and are at risk of major amputation.

The device will be used to attempt to connect an artery with a vein in the lower leg to restore blood flow to the foot.

After the procedure, there are a total of 9 follow-up visits over 3 years. The expected total time for all patients to complete the study, including enrollment and follow-up, is about 5 years.

Key Eligibility:

Inclusion criteria:

Between 18 and 95 years old
Primary wound is stable
Clinical diagnosis of chronic limb-threatening ischemia

Exclusion critera:

Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.

Detailed eligibility will be reviewed when you contact the study team.

Return to List