Percutaneous Deep Vein Arterialization Post-Market Study
概览
- 阶段
- 不适用
- 干预措施
- Percutaneous deep vein arterialization
- 疾病 / 适应症
- Critical Limb Ischemia
- 发起方
- LimFlow SA
- 入组人数
- 34
- 试验地点
- 22
- 主要终点
- Amputation-free Survival
- 状态
- 已完成
- 最后更新
- 3个月前
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.
研究者
入排标准
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
研究组 & 干预措施
Percutaneous deep vein arterialization
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
Percutaneous deep vein arterialization
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
结局指标
主要结局
Amputation-free Survival
时间窗: Throughout one year
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
次要结局
- Wound Healing(Throughout one year)
- Primary and Secondary Patency as Assessed by Duplex Ultrasound(Throughout one year)
- Limb Salvage(Throughout one year)
- Deterioration in Renal Function(One month and six months)
- Interventions With Technical Success (Procedure Completion)(Immediately post-procedure)
- Interventions With Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)(One month post-procedure)