PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
- Conditions
- Peripheral Arterial DiseaseCritical Limb IschemiaChronic Limb-Threatening Ischemia
- Interventions
- Device: LimFlow Stent Graft System
- Registration Number
- NCT05313165
- Lead Sponsor
- LimFlow, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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Subject must be ≥ 18 and ≤ 95 years of age
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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
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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.
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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.
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Subject is willing and able to sign the informed consent form.
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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.
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Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
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Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).
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Stable glycemic control, HbA1C < 10% (<269mg/dL)
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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
- 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.
- Absence of adequate viable tissue in target foot.
- 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, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated with LimFlow LimFlow Stent Graft System Treatment with the LimFlow Stent Graft System
- Primary Outcome Measures
Name Time Method Amputation Free Survival 6 Months Freedom from major (above-ankle) amputation and death (all-cause mortality)
- Secondary Outcome Measures
Name Time Method Change in Rutherford Classification 6 Months A change of one class or greater
Primary Patency 6 Months Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures
Primary Assisted Patency 6 Months 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
Secondary Patency 6 Months Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical or endovascular procedures after occlusion occurs
Limb Salvage 6 Months Percentage of subjects with freedom from above-ankle amputation of the index limb
Technical Success Intraprocedurally The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success
Radiation Exposure Intraprocedurally Patient radiation exposure (in milligray) during the procedure
Procedural Success 30 Days The combination of technical success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft
Freedom from Contrast-Induced Nephropathy 72 hours 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.
Procedure Time Intraprocedurally The time of the first puncture (venous or arterial) to when the last catheter is removed
All Wound Healing 12 Months Complete healing of the patient's wounds
Contrast Volume Intraprocedurally The total volume of contrast media (in milliliters) given during the procedure
All Wound Area Reduction 12 Months Reduction in area of the patient's wounds
Target Wound Healing 12 Months Complete healing of the patient's target wound
Trial Locations
- Locations (30)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University of California, San Diego Health
🇺🇸La Jolla, California, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
The Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Washington University / Barnes Jewish
🇺🇸Saint Louis, Missouri, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
UMass Chan Medical School
🇺🇸Worcester, Massachusetts, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Vascular Institute of Atlantic Medical Imaging
🇺🇸Pomona, New Jersey, United States
Presbyterian Healthcare
🇺🇸Albuquerque, New Mexico, United States
Penn State Health
🇺🇸Hershey, Pennsylvania, United States
Mount Sinai
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Cornell University
🇺🇸New York, New York, United States
Northwell Health Long Island Jewish Medical Center
🇺🇸Lake Success, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Yale University
🇺🇸New Haven, Connecticut, United States
NYU Langone Health
🇺🇸New York, New York, United States
The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
UCSF
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Ascension Columbia St. Mary's Hospital
🇺🇸Milwaukee, Wisconsin, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States