Single Arm, Open Label, Retrospective and Prospective Clinical Data Collection to Assess CascadeTM, Non-Occlusive Remodeling Net, in Providing Temporary Assistance for Coil Embolization of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 7
- 主要终点
- Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device
研究概览
简要总结
This study is a multi-center, single arm, open label, retrospective and prospective clinical data collection of CascadeTM, Non-Occlusive Remodeling Net, in adults with intracranial aneurysms, demonstrating the effectiveness and safety of the CascadeTM in providing temporary assistance for coil embolization of intracranial aneurysms.
All consecutive eligible patients from all participating sites will be included in this clinical data collection. The relevant data of the coil embolization procedure will be collected via an eCRF system.
Peri procedural data on the coil embolization procedure as well as discharge, 30 days and at 3-6 months status will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device
时间窗: During procedure
Successful coil embolization of the target intracranial aneurysm assisted by Cascade device, without coil entanglement, protrusion or prolapse into the parent vessel at the end of the procedure, as evaluated angiographically by a central core-lab
Main Safety Endpoint - Incidence of Serious Adverse Device Effects (SADE)
时间窗: within 30 days post procedure
Serious adverse device effects (SADE) occurring within 30 days post procedure, including the following safety events: * Vessel damage related to the use of the study device that leads to dissection, perforation, hemorrhage or vasospasm. * Thromboembolic event related to the use of the study device. * Coil entanglement
次要结局
- Secondary Efficacy Endpoint - Maintenance or improvement of aneurysm occlusion(3-6 months post procedure)