NCT01778322已完成不适用
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
Microvention-Terumo, Inc.12 个研究点 分布在 4 个国家目标入组 51 人开始时间: 2011年12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
- 51
- 试验地点
- 12
- 主要终点
- Durability of occlusion
研究概览
简要总结
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
详细描述
The following parameters will be evaluated as part of this study:
- Aneurysm morphology
- Aneurysm size
- For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)
- Size of the embolization device(s) used in the procedure
- Intra-procedural assessment of aneurysm occlusion and flow stasis
- Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)
- Aneurysm occlusion durability
- Recanalization rate
- Device-related changes in Modified Rankin Scale from baseline
- Complications/adverse events
- Rebleed/new bleed
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age
- •Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures
排除标准
- •Must not have clinical or angiographic evidence of vasospasm
- •Must not have lesion with characteristics unsuitable for endovascular treatment
- •Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
- •Must not be concurrently involved in another investigational or post-market study
- •Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
结局指标
主要结局
Durability of occlusion
时间窗: 6 months
Evaluated by the Corelab
次要结局
- Percentage occlusion of target aneurysm(6 months)
- Recurrence/recanalization rate(6 months)
- Modified Raymond Scale(6 months)
研究者
研究点 (12)
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