RECRUITING

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

Conditions

Critical Limb Ischemia Chronic Limb-Threatening Ischemia Peripheral Arterial Disease CLTI PAD CLI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-12-22

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05313165

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 95 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject must be ≥ 18 and ≤ 95 years of age 2. 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 1. Rutherford Classification 5, ischemic ulceration or 2. Rutherford Classification 6, ischemic gangrene 3. 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. 4. 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. 5. Subject is willing and able to sign the informed consent form. 6. 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. 7. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test. 8. Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing). 9. Stable glycemic control, HbA1C \< 10% (\<269mg/dL) 10. 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	1. Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days. 2. Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder. 3. Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft. 4. Absence of adequate viable tissue in target foot. 5. Life expectancy less than 12 months. 6. Documented myocardial infarction or stroke within previous 90 days. 7. 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). 8. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated. 9. 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). 10. 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). 11. Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in subjects not undergoing dialysis. 12. 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. 13. 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. 14. 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. 15. Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Inclusion Criteria

Exclusion Criteria

1. Subject must be ≥ 18 and ≤ 95 years of age
2. 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
1. Rutherford Classification 5, ischemic ulceration or
2. Rutherford Classification 6, ischemic gangrene
3. 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.
4. 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.
5. Subject is willing and able to sign the informed consent form.
6. 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.
7. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
8. Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).
9. Stable glycemic control, HbA1C \< 10% (\<269mg/dL)
10. 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

1. Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
2. Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
3. Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.
4. Absence of adequate viable tissue in target foot.
5. Life expectancy less than 12 months.
6. Documented myocardial infarction or stroke within previous 90 days.
7. 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).
8. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
9. 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).
10. 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).
11. Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in subjects not undergoing dialysis.
12. 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.
13. 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.
14. 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.
15. Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Contacts and Locations

Study Contact

Erin Towery

CONTACT

888-478-7705

etowery@limflow.com

Principal Investigator

Daniel Clair, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University

Mehdi Shishehbor

PRINCIPAL_INVESTIGATOR

University Hospital Cleveland

Study Locations (Sites)

University of California, San Diego Health

La Jolla, California, 92093

United States

Stanford University School of Medicine

Palo Alto, California, 94304

United States

UCSF

San Francisco, California, 94143

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502

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

Tallahassee Research Institute

Tallahassee, Florida, 32308

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

UMass Chan Medical School

Worcester, Massachusetts, 01655

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

Holy Name Medical Center

Teaneck, New Jersey, 07666

United States

Presbyterian Healthcare

Albuquerque, New Mexico, 87113

United States

Northwell Health Long Island Jewish Medical Center

Lake Success, New York, 11042

United States

NYU Langone Health

New York, New York, 10016

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

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507

United States

Ascension Columbia St. Mary's Hospital

Milwaukee, Wisconsin, 53211

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: LimFlow, Inc.

Daniel Clair, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University
Mehdi Shishehbor, PRINCIPAL_INVESTIGATOR, University Hospital Cleveland

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2022-12-22

Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

CLTI
PAD
CLI

Additional Relevant MeSH Terms

Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease