NCT03807661已完成不适用
Percutaneous Deep Vein Arterialization Post-Market Study
LimFlow SA6 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年12月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Amputation-free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Percutaneous deep vein arterialization
Experimental
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
干预措施: Percutaneous deep vein arterialization (Procedure)
Percutaneous deep vein arterialization
Experimental
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
干预措施: LimFlow System (Device)
结局指标
主要结局
Amputation-free Survival
时间窗: Throughout one year
Freedom from death or major amputation
次要结局
- Limb Salvage(Throughout one year)
- Wound Healing(Throughout one year)
- Primary and Secondary Patency(Throughout one year)
- Technical Success (Procedure Completion)(Immediately post-procedure (approximately 4 hours after vascular access))
- Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)(One month post-procedure)
研究者
研究点 (6)
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