PROMISE International
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A vizsgálat adatai
- Ki végzi
- LimFlow SA
- Azonosító
- NCT03321552
- A regiszteradat frissítve
- 2026. január 7.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Percutaneous Deep Vein Arterialization Post-Market Study
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's 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; Documented myocardial infarction or stroke within previous 90 days; Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft; 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; Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment; 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); Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis; 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); Life expectancy less than 12 months; Patient unable to give consent; Pregnant or breastfeeding women; Patients with vasculitis and/or untreated popliteal aneurysms; Patients with acute limb ischemia.