NCT00346515已完成不适用
Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study
Lumen Biomedical8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年6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
- 30
- 试验地点
- 8
- 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, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent 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
- 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.
- •Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
- •Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
排除标准
- •Allergy to Heparin.
- •Myocardial infarction within the last 14 days.
- •Angioplasty or PTCA/PTA procedure within the past 48 hours.
- •Cardiac surgery within the past 60 days.
- •Planned invasive surgical procedure within 30 days.
- •Stroke within the past 14 days.
- •Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
- •Intracranial stenosis that exceeded the severity of an extracranial stenosis.
- •Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.
- •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 because of one or more of:
- •Tortuous or calcified anatomy proximal or distal to the stenosis
- •Presence of visual thrombus
- •Pseudo occlusion ('string sign')
- •Serial lesions that requires more then one stent to cover entire lesion.
- •Procedural complication prior to introduction of the FiberNet device into the body.
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
- All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates
研究者
研究点 (8)
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