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

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Description

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

Study Overview

Start Date
December 22, 2022
Completion Date
May 1, 2027
Enrollment
100
Date Posted
April 6, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
UCSF
San Francisco, California 94143, United States

Yale University
New Haven, Connecticut 06519, United States

The Cardiac and Vascular Institute
Gainesville, Florida 32605, United States

University of Florida
Gainesville, Florida 32608, United States

Rush University Medical Center
Chicago, Illinois 60612, United States

Massachusetts General Hospital
Boston, Massachusetts 02114, United States

Boston Medical Center
Boston, Massachusetts 02118, United States

Washington University / Barnes Jewish
Saint Louis, Missouri 63110, United States

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766, United States

Vascular Institute of Atlantic Medical Imaging
Pomona, New Jersey 08240, United States

Presbyterian Healthcare
Albuquerque, New Mexico 87113, United States

Mount Sinai
New York, New York 10029, United States

Cornell University
New York, New York 10065, United States

Atrium Health
Charlotte, North Carolina 28204, United States

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106, United States

Penn State Health
Hershey, Pennsylvania 17033, United States

University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

Vanderbilt University Medical Center
Nashville, Tennessee 37212, United States

UT Southwestern Medical Center
Dallas, Texas 75390, United States

Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin 53211, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
95
Eligibility Criteria
Inclusion Criteria:

Subject must be ≥ 18 and ≤ 95 years of age

Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and

Rutherford Classification 5, ischemic ulceration or
Rutherford Classification 6, ischemic gangrene
Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.
Subject is willing and able to sign the informed consent form.
Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.
Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).
Stable glycemic control, HbA1C < 10% (<269mg/dL)

Subjects requiring dialysis may be included, provided they meet all the following requirements:

On dialysis for > 6 months
Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis
Serum albumin > 30 g/liter
BMI > 20

Exclusion Criteria:

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.
Absence of adequate viable tissue in target foot.
Life expectancy less than 12 months.
Documented myocardial infarction or stroke within previous 90 days.
Active infection (e.g., fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).
Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).
Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).
Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis.
Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.
Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Study Contact Info

Study Contact Name
Erin Towery
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
Detailed Description
The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
NCTid (if applicable)
NCT05313165