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

NCT03970538 | Unknown Results DMC FDA Device

• 1 other identifier: LF-CA-PR-3
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 21

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").

Conditions

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

Keywords

CLI; CLTI; Amputation; Desert Foot; PAD; Peripheral Artery Disease; Critical Limb Ischemia; Chronic Limb-Threatening Ischemia; TADV - Transcatheter Arterialization of Deep Veins; DVA - Deep Vein Arterialization

Outcome Measures

Primary Outcomes (1)

• Amputation Free Survival (AFS)

  freedom from major amputation and death at 6 months, compared to a historical performance goal.

  6 months post-procedure

Secondary Outcomes (32)

• Primary Patency

  30 days post procedure

• Primary Assisted Patency

  6 months post-procedure

• Secondary Patency

  30 days post-procedure

• Limb Salvage

  30 days post-procedure

• Change in Rutherford Classification

  30 days post-procedure

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Treated with the LimFlow System

Device: LimFlow System

Interventions

LimFlow System DEVICE

Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be ≥18 and ≤ 95 years of age
• 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
• Rutherford Classification 5, ischemic ulceration or
• Rutherford Classification 6, ischemic gangrene
• 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.
• 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.
• Prior stent(s) to the infrainguinal arteries (e.g. iliac, SFA, and popliteal) are allowed.
• Planned minor amputation (e.g. partial toe, ray or proximal foot/transmetatarsal) of target extremity within 30 days after the index procedure is allowed.
• Subject is willing and able to sign the informed consent form.
• 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.
• Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
• Primary wound is stable (e.g. not rapidly deteriorating and/or showing signs of healing)
• Stable glycemic control, HbA1C \< 10% (\<269mg/dL)
• Subjects requiring dialysis may be included, provided they meet all the following requirements:
• On dialysis for \> 6 months

You may not qualify if:

• 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.
• Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
• 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.
• Previous major amputation of the target limb or presence of a wound requiring a free flap or absence of adequate viable tissue.
• Life expectancy less than 12 months.
• Documented myocardial infarction or stroke within previous 90 days.
• 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).
• Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
• 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).
• 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).
• Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in subjects not undergoing dialysis.
• 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.
• 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.
• 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.
• \) Subject is unwilling, or unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Sponsors & Collaborators

• LimFlow, Inc.: lead

Study Sites (21)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Unitypoint Health

Des Moines, Iowa, 50309, United States

Location

Ochsner Health System

Kenner, Louisiana, 70065, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Saint Luke's Hospital

Lee's Summit, Missouri, 64086, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Coastal Carolina Surgical Associates

Wilmington, North Carolina, 28401, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Prisma Health -- Midlands

Columbia, South Carolina, 29203, United States

Location

Prisma Health -- Upstate

Greenville, South Carolina, 29615, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Seton Heart

Austin, Texas, 78723, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Ponce Medical School

Ponce, 00731, Puerto Rico

Location

Related Publications (1)

• Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martinez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023 Mar 30;388(13):1171-1180. doi: 10.1056/NEJMoa2212754.

  PMID: 36988592 RESULT

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Director, Clinical Affairs
• Organization: LimFlow

kmccaffrey@limflow.com

559-970-1012

Study Officials

• Daniel Clair, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Mehdi Shishehbor

  University Hospital Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center pivotal study

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: December 6, 2019
• Primary Completion: September 9, 2022
• Study Completion: February 28, 2025
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); PR (1)