Summary

Eligibility
for people ages 18-94 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Mark Archie (ucla)

Description

Summary

The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular treatment option (i.e., "no option").

Official Title

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

Details

The objective of this US pivotal trial is to investigate the safety and effectiveness of 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 (CLTI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Keywords

Critical Limb Ischemia Critical Lower Limb Ischemia Peripheral Artery Disease Peripheral Arterial Disease Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arterial Occlusion Arterial Disease Peripheral Artery Occlusion Peripheral Vascular Disease Peripheral Ischemia Vascular Diseases CLI CLTI Amputation Desert Foot PAD Peripheral Vascular Diseases Ischemia LimFlow System

Eligibility

You can join if…

Open to people ages 18-94

  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
  3. Rutherford Classification 5, ischemic ulceration or
  4. Rutherford Classification 6, ischemic gangrene
  5. Subject has been assessed by the principal investigator, reviewed by the Independent Review Committee (IRC), 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.
  6. 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.
  7. Prior stent(s) to the infrainguinal arteries (e.g. iliac, SFA, and popliteal) are allowed.
  8. Planned minor amputation (e.g. partial toe, ray or proximal foot/transmetatarsal) of target extremity within 30 days after the index procedure is allowed.
  9. Subject is willing and able to sign the informed consent form.
  10. 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.
  11. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
  12. . Primary wound is stable (e.g. not rapidly deteriorating and/or showing signs of healing)
  13. . Stable glycemic control, HbA1C < 10% (<269mg/dL)
  14. . Subjects requiring dialysis may be included, provided they meet all the following requirements:
  15. On dialysis for > 6 months
  16. Autologous arteriovenous (AV) fistula access used for hemodialysis
  17. Serum albumin > 30 g/liter
  18. BMI > 20

You CAN'T join if...

  1. Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the endovascular procedure: 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 or interventional revascularization procedure within 30 days.
  4. Previous major amputation of the target limb or presence of a wound requiring a free flap.
  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 or unable to comply with any of the protocol or follow-up requirements.

Locations

  • Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Baylor College of Medicine accepting new patients
    Houston Texas 77030 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
LimFlow, Inc.
ID
NCT03970538
Study Type
Interventional
Last Updated