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

LimFlow, Inc.21 sites in 2 countries105 target enrollmentDecember 6, 2019

ConditionsCritical 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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Limb Ischemia
Sponsor: LimFlow, Inc.
Enrollment: 105
Locations: 21
Primary Endpoint: Amputation Free Survival (AFS)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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").

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.

Registry

clinicaltrials.gov

Start Date

December 6, 2019

End Date

February 28, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

LimFlow, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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).

Outcomes

Primary Outcomes

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 Outcomes

Change in Rutherford Classification(6 months post-procedure)
Target Wound Healing(12 months post-procedure)
Contrast Volume(During the procedure)
Primary Assisted Patency(6 months post-procedure)
Secondary Patency(6 months post-procedure)
Technical Success(Immediately post-procedure)
Primary Patency(6 months post procedure)
All Wound Healing(12 months post-procedure)
Limb Salvage(6 months days post-procedure)
Procedure Time(Immediately post-procedure)
Radiation Exposure(During the procedure)
Procedure Success(30 days post-procedure)
Freedom From Contrast-Induced Nephropathy(Within the first 72 hours post-procedure)
All Wound Area Reduction(12 months post-procedure)