Summary

Eligibility
for people ages 18-95 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Ann Gaffey

Description

Summary

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

Details

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.

Keywords

Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, CLTI, PAD, CLI, Peripheral Vascular Diseases, Ischemia, LimFlow Stent Graft System

Eligibility

You can join if…

Open to people ages 18-95

  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

You CAN'T join if...

  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.

Locations

  • University of California, San Diego Health accepting new patients
    La Jolla California 92093 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States

Lead Scientist at UCSD

  • Ann Gaffey
    Assistant Professor In Residence, Surgery, Vc-health Sciences-schools. Authored (or co-authored) 47 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
LimFlow, Inc.
ID
NCT05313165
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated