NCT02390037已完成不适用
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Medtronic Neurovascular Clinical Affairs7 个研究点 分布在 6 个国家目标入组 50 人开始时间: 2015年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Occurrence of major stroke or neurological death
研究概览
简要总结
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
- •Age 18-80 years.
- •Subject has already been selected for flow diversion therapy as the appropriate treatment.
- •Subject has an unruptured target intracranial aneurysm (IA).
- •Subject has a target IA located in the anterior or posterior circulation.
排除标准
- •Major surgery in the past 30 days.
- •Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use.
- •Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
结局指标
主要结局
Occurrence of major stroke or neurological death
时间窗: 1 year
次要结局
- Device related neurologic adverse event rate(1 year)
研究者
研究点 (7)
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