WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 26
- 主要终点
- Rate of Stroke or Death Among Participants
研究概览
简要总结
The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.
详细描述
This research study is a Food and Drug Administration (FDA) mandated post market surveillance study of the Wingspan® Stent System, also known as the WEAVE™ Trial. The purpose of this trial is to fulfill a FDA requirement to evaluate the rate of stroke and/or death within 72 hours of the procedure, in patients who have a Wingspan Stent implanted in accordance with the Indications for Use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients for whom treatment with the Wingspan Stent System is considered.
排除标准
- 未提供
研究组 & 干预措施
Wingspan Stent System
Placement of the Wingspan Stent
干预措施: Wingspan Stent System (Device)
结局指标
主要结局
Rate of Stroke or Death Among Participants
时间窗: within 72 hours of the procedure
The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic cause and is detectable on examination at least 24 hours after onset of symptoms. Hemorrhagic stroke was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging.
次要结局
- Rate of Ischemic Stroke Among Participants(within 72 hours post procedure)
- Rate of Neurological Death Among Participants(within 72 hours post procedure)
- Rate of Stroke in the Territory of the Stented Artery Among Participants(within 72 hours post procedure)
- Rate of Stroke Recovery Among Participants(at 90 days post procedure)