PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Completed · Not applicable

Conditions studied: Critical Limb Ischemia, Chronic Limb-Threatening Ischemia

In brief

This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Key facts

Study ID

NCT03124875

Run by

LimFlow, Inc.

People needed

32

Starts

2017-07-05

Expected to finish

2021-01-05

Last updated by the study team

2024-05-21

Who can join

Age: 21 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of critical limb ischemia with hemodynamic evidence of severely diminished arterial inflow of the index limb and Rutherford Classification 5 r 6
• Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)

You may not qualify if…

• Concomitant hepatic or renal insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder
• Severe heart failure, recent MI or stroke
• Significant peripheral edema or infection that may preclude insertion of a prosthesis or significantly impair wound healing
• Known allergies or contraindications to anti platelet therapy or device materials
• Immunodeficiency disorder or immunosuppressant therapy
• Life expectancy < 12 months

Where it is running

• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Kaiser Permanente — Honolulu, Hawaii, United States
• Metro Health, University of Michigan — Wyoming, Michigan, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Mount Sinai Health System — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Palmetto Health — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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