NCT00460187已完成不适用
Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.
Lumen Biomedical4 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 4
- 主要终点
- The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
研究概览
简要总结
Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •One or more of the high surgical risk criteria.
- •Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
排除标准
- •Prior stenting of ipsilateral carotid.
- •Planned treatment of contralateral carotid within 30 days.
- •Experienced a myocardial infarction within the last 14 days.
- •Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours.
- •Undergone cardiac surgery within the past 60 days.
- •Suffered a stroke within the past 14 days.
- •Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
- •Abnormal baseline blood counts; platelets <50,000 or >700,000/mm3 or WBC count < 3 x103/uL.
- •Intracranial stenosis that exceeded the severity of an extracranial stenosis.
- •Total occlusion of the target vessel.
- •Lesion within 2cm of the ostium of the common carotid artery.
- •A stenosis that is known to be unsuitable for stenting
- •Serial lesions that requires more than one stent to cover entire lesion.
结局指标
主要结局
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
次要结局
- Secondary Endpoints are: all death and all stroke rates, non-stroke neurological event rates, technical success rates, procedural success rates, and access site complication rates.
研究者
研究点 (4)
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