CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 4
- 主要终点
- Aneurysm occlusion
研究概览
简要总结
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.
详细描述
All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.
Subjects will be followed per Institution's standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 must be ≥ 18 years of age and ≤80 years of age
- •Subject must have an intracranial aneurysm (IA),
- •Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
- •For ruptured aneurysm, Subject with Hunt & Hess Score ≤ III
排除标准
- •Subject has an IA with characteristics unsuitable for endovascular treatment
- •Subject's index IA was previously treated
- •Subject has stroke-in-evolution within the prior 30 days
- •An additional aneurysm must be treated during the procedure
结局指标
主要结局
Aneurysm occlusion
时间窗: 12 months
Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. * class I: complete obliteration * class II: residual neck * class III: residual aneurysm
Incidence of major stroke or neurological deaths
时间窗: 12months
The proportion of subjects with death of any nonaccidental cause or any major stroke 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