NCT02780349已完成不适用
Evaluation of WIRION™ EPS in Lower Extremities Arteries
Gardia Medical17 个研究点 分布在 2 个国家目标入组 103 人开始时间: 2016年5月1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
- 103
- 试验地点
- 17
- 主要终点
- Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.
研究概览
简要总结
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age
- •Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
- •Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
- •Rutherford classification 2-4
- •Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
- •Planned atherectomy of the native femoropopliteal arteries
- •Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm
- •An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm
- •A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study
排除标准
- •Any planned surgical or endovascular intervention within 30 days before or after the index procedure
- •A lesion deemed not accessible by the WIRION™ EPS
- •Inability to take aspirin or ADP receptor antagonists
- •History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
- •Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
- •Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded)
- •Life expectancy less than 12 months
- •Known severe renal insufficiency (eGFR <30 ml/min/1.72m2).
- •≤1-vessel tibial run-off status
研究组 & 干预措施
WIRION EPS
Experimental
Single arm study. All patients undergo procedure with the WIRION EPS
干预措施: WIRION (Device)
结局指标
主要结局
Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.
时间窗: 30 days
MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)
次要结局
未报告次要终点
研究者
研究点 (17)
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