International Retrospective Study of Pipeline Embolization Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 793
- 试验地点
- 16
- 主要终点
- Relative incidence of neurologic clinical events that occurred after treatment with PED
研究概览
简要总结
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed to observe and capture information from numerous hospitals.
Data collection will be initiated starting March 2012 and continue until approximately April 2017.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
排除标准
- 未提供
结局指标
主要结局
Relative incidence of neurologic clinical events that occurred after treatment with PED
时间窗: From Approval of PED in country of use until IRB approval at facility allowing for approximately 8-12 months of data for each subject. Outcomes are expected to be reported on 6 mo, 12mo, 2 yr, & 5yr data.
Incidence of neurologic events from the time of Approval of the Pipeline Embolization Device in the country of use until IRB approval at facility.
次要结局
未报告次要终点