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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03970538
Other study ID # LF-CA-PR-3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 6, 2019
Est. completion date February 28, 2025

Study information

Verified date January 2024
Source LimFlow, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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").


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date February 28, 2025
Est. primary completion date September 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Puerto Rico Ponce Medical School Ponce
United States New Mexico Heart Institute Albuquerque New Mexico
United States Seton Heart Austin Texas
United States Boston Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Atrium Health Charlotte North Carolina
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Prisma Health -- Midlands Columbia South Carolina
United States Unitypoint Health Des Moines Iowa
United States The Cardiac and Vascular Institute Gainesville Florida
United States University of Florida Gainesville Florida
United States Prisma Health -- Upstate Greenville South Carolina
United States Baylor College of Medicine Houston Texas
United States Ochsner Health System Kenner Louisiana
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's Hospital Lee's Summit Missouri
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States University of California San Francisco San Francisco California
United States Harbor-UCLA Medical Center Torrance California
United States Coastal Carolina Surgical Associates Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
LimFlow, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & 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. 20 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Amputation Free Survival (AFS) freedom from major amputation and death at 6 months, compared to a historical performance goal. 6 months post-procedure
Secondary Primary Patency Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures. 30 days post procedure
Secondary Primary Assisted Patency 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. 6 months post-procedure
Secondary Secondary Patency Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs. 30 days post-procedure
Secondary Limb Salvage The percentage of subjects with freedom from above-ankle amputation of the index limb. 30 days post-procedure
Secondary Change in Rutherford Classification A decrease in Rutherford class number (i.e.: from Rutherford class 5 to 4) is clinical improvement 30 days post-procedure
Secondary Technical Success The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success. Immediately post-procedure
Secondary Procedure Success Combination of Technical Success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft. 30 days post-procedure
Secondary Target Wound Healing Complete healing of the patient's target wound 30 days post-procedure
Secondary All Wound Healing Complete healing of the patient's wounds. 30 days post-procedure
Secondary Freedom From Contrast-Induced Nephropathy 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. Within the first 72 hours post-procedure
Secondary Procedure Time Time from the first puncture (venous or arterial) to when the last catheter is removed Immediately post-procedure
Secondary Radiation Exposure Patient radiation exposure (measured in milligray) During the procedure
Secondary Contrast Volume Total volume of contrast media (measured in milliliters) During the procedure
Secondary All Wound Area Reduction Defined as reduction in area of the patient's wounds 30 days post-procedure
Secondary Primary Patency Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures. 6 months post procedure
Secondary Secondary Patency Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs. 6 months post-procedure
Secondary Limb Salvage The percentage of subjects with freedom from above-ankle amputation of the index limb. 3 months days post-procedure
Secondary Limb Salvage The percentage of subjects with freedom from above-ankle amputation of the index limb. 6 months days post-procedure
Secondary Change in Rutherford Classification A change of one Rutherford class or greater. 3 months post-procedure
Secondary Change in Rutherford Classification A change of one Rutherford class or greater. 6 months post-procedure
Secondary Target Wound Healing Complete healing of the patient's target wound 3 months post-procedure
Secondary Target Wound Healing Complete healing of the patient's target wound 6 months post-procedure
Secondary Target Wound Healing Complete healing of the patient's target wound 9 months post-procedure
Secondary Target Wound Healing Complete healing of the patient's target wound 12 months post-procedure
Secondary All Wound Area Reduction Defined as reduction in area of the patient's wounds 3 months post-procedure
Secondary All Wound Area Reduction Defined as reduction in area of the patient's wounds 6 months post-procedure
Secondary All Wound Area Reduction Defined as reduction in area of the patient's wounds 9 months post-procedure
Secondary All Wound Area Reduction Defined as reduction in area of the patient's wounds 12 months post-procedure
Secondary All Wound Healing Complete healing of the patient's wounds. 3 months post-procedure
Secondary All Wound Healing Complete healing of the patient's wounds. 6 months post-procedure
Secondary All Wound Healing Complete healing of the patient's wounds. 9 months post-procedure
Secondary All Wound Healing Complete healing of the patient's wounds. 12 months post-procedure
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