COMPLEX Post Market Surveillance Electronic Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 2
- 主要终点
- To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms
研究概览
简要总结
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
详细描述
This Post Market Surveillance Registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial aneurysms treated with the Trufill DCS Orbit detachable platinum coils.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with angiographically documented aneurysms,
- •Either ruptured or unruptured,
- •Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization
排除标准
- •1) Patient / Treatment outside of the approved labeling, indications for use.
研究组 & 干预措施
Trufill Detachable Coil System
There is only one treatment arm in the registry and it is all patients receiving treatment with Trufill Detachable Coil System. The use of bare platinum coils for the endovascular occlusion of cerebral aneurysms.
干预措施: Endovascular Embolization Device (Device)
结局指标
主要结局
To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms
时间窗: Between 3-6 months
次要结局
- Adverse events and product complaints(Ongoing throughout study)