Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- any recurrence rate after treatment
研究概览
简要总结
Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.
详细描述
The investigators aimed to analyze whether the use of second-generation hydrogel coils for the treatment of ruptured intracranial aneurysms improves clinical and angiographic outcomes compared with the use of bare platinum coils.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 year old or older
- •untreated ruptured intracranial aneurysms with an anatomy such that endovascular treatment with either bare platinum or second-generation hydrogel coils was considered feasible.
- •person who agreed to study
排除标准
- •contrast allgery (+)
- •combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases)
- •ineligible for coil embolization
研究组 & 干预措施
Bare platinum coil group
Treatment using bare metal coil only for ruptured cerebral aneurysms
干预措施: Coil embolization (Device)
Second-generation hydrogel coil group
Treatment using second-generation hydrogel coils (had to constitute > 50% of the total coil length) for ruptured cerebral aneurysms
干预措施: Coil embolization (Device)
结局指标
主要结局
any recurrence rate after treatment
时间窗: during 12 months after coil embolization
any recurrence rate at 12 months after coil embolization
次要结局
- rate of retreatment during 12 months follow-up period(rate of retreatment during 12 months follow-up period)
- packing density (%) after coil embolization(packing density (%) after coil embolization)
- rate of ventriculoperitoneal shunt during 12-month follow-up period(rate of ventriculoperitoneal shunt during 12-month follow-up period)
- rate of retreatment during 12 months follow-up period(rate of retreatment during 12 months follow-up period)
- packing density (%) after coil embolization(packing density (%) after coil embolization)
- Procedural complication(during coil embolization)
- delayed cerebral ischemia during 12-month follow-up period(delayed cerebral ischemia during 12-month follow-up period)
- good clinical outcome (mRS score ≤ 2) at 12-month follow-up period(good clinical outcome (mRS score ≤ 2) at 12-month follow-up period)
- rate of ventriculoperitoneal shunt during 12-month follow-up period(rate of ventriculoperitoneal shunt during 12-month follow-up period)
- coil's ease of manipulation(during coil embolization)