NCT00530504已完成不适用
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Medtronic Endovascular2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2007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
- 1,500
- 试验地点
- 2
- 主要终点
- Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
研究概览
简要总结
The purposes of this study are:
- To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.
- To evaluate rare and unanticipated adverse events.
- To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
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
- •18 years and above
- •Informed consent
- •Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use
- •Meet Instruction for Use (IFU)/ Centers for Medicare & Medicaid Services (CMS)defined anatomical or clinical high risk criteria
排除标准
- •Subjects with contraindications as outlined in the Instructions for Use
研究组 & 干预措施
Device
Experimental
Device
干预措施: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device (Device)
结局指标
主要结局
Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
时间窗: 30 Days
Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
次要结局
未报告次要终点
研究者
研究点 (2)
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