PROMISE International

Study Overview
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Brief Summary
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The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

Detailed Description
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This study will investigate the safety and effectiveness of the LimFlow System for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Official Title
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Percutaneous Deep Vein Arterialization Post-Market Study

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Procedure: Percutaneous deep vein arterialization
* Device: LimFlow System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be > 21 and < 95 years of age Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6 Assessment that no conventional surgical or endovascular treatment is possible Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be <50% stenosed Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits Exclusion Criteria: Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study Life expectancy less than 12 months Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment Patient 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 treatment Patient unable to give consent Pregnant or breastfeeding women Documented myocardial infarction or stroke within previous 90 days Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis Patients with vasculitis and/or untreated popliteal aneurysms Patients with acute limb ischemia Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3) Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of < 40%, NYHA Classification III-IV)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous deep vein arterialization<br>Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach | Procedure: Percutaneous deep vein arterialization<br>* Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach<br>Device: LimFlow System<br>* Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation-free survival | Freedom from death or major amputation | Throughout one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Complete index wound healing as assessed by wound pictures | Throughout one year | 
| Primary and secondary patency as assessed by duplex ultrasound | Stent graft patency as assessed by duplex ultrasound | Throughout one year | 
| Limb salvage: Freedom from major amputation | Freedom from major amputation | Throughout one year | 
| Deterioration in renal function as assessed by creatinine level | Changes in creatinine level | One month and six months | 
| Technical success (procedure completion) | Procedure completion and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft | Immediately post-procedure | 
| Procedural success (technical success without death, major amputation, or re-intervention) | Combination of technical success without death, major amputation, or re-intervention | One month post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Desert foot, No-option patients, Venous arterialization