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The PROMISE II Trial, Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia (PROMISE)

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ClinicalTrials.gov Identifier: NCT03970538
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
LimFlow, Inc.

Brief 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").

Condition or disease Intervention/treatment Phase
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 Device: LimFlow System Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multi-center pivotal study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : December 30, 2023

Arm Intervention/treatment
Experimental: Treatment Arm
Treated with the LimFlow System
Device: LimFlow System
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia




Primary Outcome Measures :
  1. Amputation Free Survival (AFS) [ Time Frame: 6 months post-procedure ]
    freedom from major amputation and death at 6 months, compared to a historical performance goal.


Secondary Outcome Measures :
  1. Primary Patency [ Time Frame: 30 days and 6 months post-procedure ]
    Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.

  2. Primary Assisted Patency [ Time Frame: 30 days and 6 months post-procedure ]
    Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred.

  3. Secondary Patency [ Time Frame: 30 days and 6 months post-procedure ]
    Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.

  4. Limb Salvage [ Time Frame: 30 days, 3 and 6 months post-procedure ]
    The percentage of subjects with freedom from above-ankle amputation of the index limb.

  5. Change in Rutherford Classification [ Time Frame: 30 days, 3 and 6 months post-procedure ]
    A change of one Rutherford class or greater.

  6. Technical Success [ Time Frame: Immediately post-procedure ]
    The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success.

  7. Procedure Success [ Time Frame: 30 days post-procedure ]
    Combination of Technical Success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft.

  8. Target Wound Healing [ Time Frame: 30 days, 3, 6, 9, and 12 months post-procedure ]
    Complete healing of the patient's target wound

  9. All Wound Healing [ Time Frame: 30 days, 3, 6, 9, and 12 months post-procedure ]
    Complete healing of the patient's wounds.

  10. Freedom from Contrast-Induced Nephropathy [ Time Frame: Within the first 72 hours post-procedure ]
    Subjects without acute (within 72 hours after intravenous contrast administration) impairment of renal function, measured as an absolute ≥0.5 mg/dL (44 µmol/L) increase compared to baseline SCr value that results in a value above the upper limit of the normal range.

  11. Procedure Time [ Time Frame: Immediately post-procedure ]
    Time from the first puncture (venous or arterial) to when the last catheter is removed

  12. Radiation Exposure [ Time Frame: During the procedure ]
    Patient radiation exposure (measured in milligray)

  13. Contrast Volume [ Time Frame: During the procedure ]
    Total volume of contrast media (measured in milliliters)

  14. All Wound Area Reduction [ Time Frame: 30 days, 3, 6, 9, and 12 months post-procedure ]
    Defined as reduction in area of the patient's wounds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 94 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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.
  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. Prior stent(s) to the infrainguinal arteries (e.g. iliac, SFA, and popliteal) are allowed.
  6. Planned minor amputation (e.g. partial toe, ray or proximal foot/transmetatarsal) of target extremity within 30 days after the index procedure is allowed.
  7. Subject is willing and able to sign the informed consent form.
  8. 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.
  9. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
  10. Primary wound is stable (e.g. not rapidly deteriorating and/or showing signs of healing)
  11. Stable glycemic control, HbA1C < 10% (<269mg/dL)
  12. 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. 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 or absence of adequate viable tissue.
  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. 15) Subject is unwilling, or unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970538


Contacts
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Contact: Thomas Engels 888-478-7705 ext 101 Tengels@limflow.com
Contact: Cecilia Petrella 3342024307 cpetrella@limflow.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
LimFlow, Inc.
Investigators
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Principal Investigator: Daniel Clair, MD Prisma Health
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Responsible Party: LimFlow, Inc.
ClinicalTrials.gov Identifier: NCT03970538    
Other Study ID Numbers: LF-CA-PR-3
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by LimFlow, Inc.:
CLI
CLTI
Amputation
Desert Foot
PAD
Peripheral Artery Disease
Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis