NCT03366818已完成不适用
Efficacy and Safety of VERSI System for Acute Ischemic Stroke
Kobe City General Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年9月21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
- 10
- 试验地点
- 1
- 主要终点
- incidence of treatment-related severe adverse event
研究概览
简要总结
To confirm efficacy and safety of VERSI system for acute ischemic stroke
详细描述
Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •onset to treat within 8 hours
- •NIHSS 8 or more
- •ASPECTS 5 or more
- •Target vessel is ICA, MCA, VA, BA, PCA
- •non-eligible or failed IV rt-PA
排除标准
- •known hemorrhagic tendency
- •arterial dissection, vasculitis
- •allergy for contrast media
- •other inappropriate condition
研究组 & 干预措施
thrombectomy
Experimental
thrombectomy by Versi system
干预措施: thrombectomy (Device)
结局指标
主要结局
incidence of treatment-related severe adverse event
时间窗: within 24 hours after procedure
symptomatic intracranial hemorrhage
次要结局
- all intracralnial hemorrhage(within 24 hours after procedure)
- Severe adverse event related to device(within 24 hours after procedure)
- recanalization ability of device(immediatry after procedure)
- recovery to independent life {modified Rankin score of 2 or less](90days after procedure)
- acceptable clinical outcome(90days after procedure)
研究者
Nobuyuki Sakai
Director, Neurosurgery
Kobe City General Hospital
研究点 (1)
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