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Minimally invasive treatment for severe leg blood flow issues

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

Not applicable Interventional LimFlow, Inc. · NCT05313165

This study is testing a new, less invasive treatment for people with severe leg blood flow problems who can't have regular surgery to see if it helps improve their condition.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 95 Years
SexAll
SponsorLimFlow, Inc. Industry-sponsored
Locations30 sites (La Jolla, California and 29 other locations)
Trial IDNCT05313165 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the LimFlow System, which utilizes a minimally invasive technique to create an arteriovenous connection in the below-the-knee vascular system. It targets patients suffering from chronic limb-threatening ischemia who are not candidates for traditional surgical or endovascular treatments. The study is prospective and single-arm, meaning all participants will receive the same intervention without a control group. The goal is to gather additional data on the effectiveness and safety of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 95 with chronic limb-threatening ischemia who cannot undergo conventional limb salvage procedures.

Not a fit: Patients with viable options for conventional surgical or endovascular therapies will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow and healing in patients with severe limb ischemia, potentially preventing amputations.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating severe limb ischemia using minimally invasive techniques.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

Exclusion Criteria:

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.

Where this trial is running

La Jolla, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Critical Limb IschemiaChronic Limb-Threatening IschemiaPeripheral Arterial DiseaseCLTIPADCLI
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.