RecruitingNot ApplicableNCT05313165

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

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

Sponsor

LimFlow, Inc.

Enrollment

100 participants

Start Date

Dec 22, 2022

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease Chronic Limb Threatening Ischemia Critical Limb Ischemia

Summary

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Eligibility

Min Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

PROMISE III tests a procedure called percutaneous deep vein arterialization (pDVA) using the LimFlow system to save limbs in patients with the most severe form of peripheral artery disease - chronic limb-threatening ischemia (CLTI) with wounds or gangrene - when conventional bypass is no longer possible. You may be eligible if: - You are 18-95 years old - You have severe limb-threatening ischemia with ischemic ulcers or gangrene (Rutherford 5 or 6) - Your ankle blood pressure or tissue oxygen levels are critically low - There is no viable option for conventional bypass or endovascular treatment You may NOT be eligible if: - You have active liver disease or untreated blood clotting disorders - You had a heart attack or stroke within the past 90 days - You have severe heart failure (NYHA Class IV) - Your life expectancy is under 12 months - There is an active infection with signs of bone involvement above the foot - You are allergic to aspirin, blood thinners, stainless steel, or contrast dye - You have significant kidney disease (creatinine over 2.5 mg/dL and not on dialysis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELimFlow Stent Graft System

Creation of an arteriovenous fistula in the desired limb location

Locations(30)

University of California, San Diego Health

La Jolla, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

UCSF

San Francisco, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Yale University

New Haven, Connecticut, United States

The Cardiac and Vascular Institute

Gainesville, Florida, United States

University of Florida

Gainesville, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

UMass Chan Medical School

Worcester, Massachusetts, United States

Washington University / Barnes Jewish

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Vascular Institute of Atlantic Medical Imaging

Pomona, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Presbyterian Healthcare

Albuquerque, New Mexico, United States

Northwell Health Long Island Jewish Medical Center

Lake Success, New York, United States

NYU Langone Health

New York, New York, United States

Mount Sinai

New York, New York, United States

Cornell University

New York, New York, United States

Atrium Health

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Penn State Health

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Ascension Columbia St. Mary's Hospital

Milwaukee, Wisconsin, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05313165

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