Clinical trial NCT05313165: PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Official title: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease
Keywords: CLTI
PAD
CLI
Lead sponsor: LimFlow, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Amputation Free Survival
timeFrame: 6 Months
Secondary outcomes:
measure: Primary Patency
timeFrame: 30 Days
measure: Primary Patency
timeFrame: 6 Months
measure: Primary Assisted Patency
timeFrame: 30 Days
measure: Primary Assisted Patency
timeFrame: 6 Months
measure: Secondary Patency
timeFrame: 30 Days
measure: Secondary Patency
timeFrame: 6 Months
measure: Limb Salvage
timeFrame: 30 Days
measure: Limb Salvage
timeFrame: 3 Months
measure: Limb Salvage
timeFrame: 6 Months
measure: Change in Rutherford Classification
timeFrame: 30 Days
measure: Change in Rutherford Classification
timeFrame: 3 Months
measure: Change in Rutherford Classification
timeFrame: 6 Months
measure: Technical Success
timeFrame: Intraprocedurally
measure: Procedural Success
timeFrame: 30 Days
measure: Target Wound Healing
timeFrame: 30 Days
measure: Target Wound Healing
timeFrame: 3 Months
measure: Target Wound Healing
timeFrame: 6 Months
measure: Target Wound Healing
timeFrame: 12 Months
measure: All Wound Healing
timeFrame: 30 Days
measure: All Wound Healing
timeFrame: 3 Months
measure: All Wound Healing
timeFrame: 6 Months
measure: All Wound Healing
timeFrame: 12 Months
measure: All Wound Area Reduction
timeFrame: 30 Days
measure: All Wound Area Reduction
timeFrame: 3 Months
measure: All Wound Area Reduction
timeFrame: 6 Months
measure: All Wound Area Reduction
timeFrame: 12 Months
measure: Freedom from Contrast-Induced Nephropathy
timeFrame: 72 hours
measure: Procedure Time
timeFrame: Intraprocedurally
measure: Radiation Exposure
timeFrame: Intraprocedurally
measure: Contrast Volume
timeFrame: Intraprocedurally
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego Health
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University / Barnes Jewish
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Pomona
country: United States
facility: Vascular Institute of Atlantic Medical Imaging
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Healthcare
state: New Mexico
city: Lake Success
country: United States
facility: Northwell Health Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Ascension Columbia St. Mary's Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Vanderbilt University
name: Daniel Clair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Cleveland
name: Mehdi Shishehbor
role: PRINCIPAL_INVESTIGATOR
References: