PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
NCT ID: NCT05313165
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-12-22
2027-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treated with LimFlow
Treatment with the LimFlow Stent Graft System
LimFlow Stent Graft System
Creation of an arteriovenous fistula in the desired limb location
Interventions
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LimFlow Stent Graft System
Creation of an arteriovenous fistula in the desired limb location
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
95 Years
ALL
No
Sponsors
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LimFlow, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Clair, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Mehdi Shishehbor
Role: PRINCIPAL_INVESTIGATOR
University Hospital Cleveland
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LF-CA-PR-53
Identifier Type: -
Identifier Source: org_study_id
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