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

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 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.
• 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.
• Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
• Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).
• Stable glycemic control, HbA1C \< 10% (\<269mg/dL)
• 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

Exclusion criteria

• 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.