NCT01516658已完成不适用
Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
Kobe City General Hospital2 个研究点 分布在 1 个国家目标入组 431 人开始时间: 2012年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 431
- 试验地点
- 2
- 主要终点
- recanalization within 1 year after embolization
研究概览
简要总结
HYBRID study is prospective randomized open label controlled multi center trial, to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.
详细描述
At least one Hydrocoil have to use in Hydrocoil arm, and only bare platinum coil have to use in Control arm.
Primary endpoint is recanalization within 1 year after embolization, and secondary endpoint are:
- aneurysmal rupture within 1 year after embolization
- any event within 30 days after embolization
- recanalization within 6 months after embolization
- aneurysmal retreatment within 1 year after embolization
- aneurysmal rupture and any death within 1 year after embolization
- any stroke within 1 year after embolization
- any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
- change in aneurysmal occlusion
- any comlicaion within 1 year after embolization
- %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •saccular intracranial aneurysm
- •endovascular treatment scheduled within 60days after consent
- •20-79 years old
- •unruptured, chronic SAH or acurte SAH Grade 1-III
- •7-20mm in size
- •1 year follow up possibel
- •independent (mRS 0-2)
- •document consent
排除标准
- •previous endovascular treated
- •additional aneurysm scheduled of endovascular treatment
- •ineligible for study
研究组 & 干预措施
Hydrogel coil group
Experimental
use Hydrogel Coil as much as be able to use
干预措施: Hydrogel coil (Device)
Bare platinum coil group
Active Comparator
use only bare platinum coil
干预措施: Bare platinum coil (Device)
结局指标
主要结局
recanalization within 1 year after embolization
时间窗: 1 year
次要结局
- change in aneurysmal occlusion(1 year)
- any complicaion within 1 year after embolization(1 year)
- aneurysmal rupture and any death within 1 year after embolization(1 year)
- aneurysmal retreatment within 1 year after embolization(1 year)
- any stroke within 1 year after embolization(1 year)
- any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization(1 year)
- aneurysmal rupture within 1 year after embolization(1 year)
- any event within 30 days after embolization(30 days)
研究者
Nobuyuki Sakai
Director of Neurosurgery
Kobe City General Hospital
研究点 (2)
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