percutaneous deep vein arterialization post-market study

Conditions: Critical Limb Ischemia

Summary: 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.

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.

Eligibility criteria:
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)

Keywords: desert foot no-option patients venous arterialization