WEB® Intrasaccular Therapy Study China Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis
研究概览
简要总结
This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.
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
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient whose age ≥ 18 and ≤75 years old
- •Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
- •Patient must sign and date IRB/EC approved written informed consent prior to initiate of any study procedures
排除标准
- •Patient has an IA with characteristics unsuitable for endovascular treatment
- •Patient has stroke-in-evolution within the prior 60-days
- •Patient has had an SAH(subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
- •Patient's index IA was previously treated
- •Patient is pregnant
结局指标
主要结局
Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis
时间窗: 12 month
Proportion of complete (angiographic) aneurysm occlusion as assessed by Core Lab without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (\>50% stenosis) at one year after treatment.
Primary Safety Endpoint: Proportion of death and major stroke
时间窗: 12 month
Proportion of death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.
次要结局
未报告次要终点