jRCT1032240364已完成不适用
Post-marketing observational study on the efficacy and safety of NeuroGuideWire for the treatment of stroke and aneurysm (C-AISIA)
ASAHI INTECC. CO., LTD.0 个研究点目标入组 30 人开始时间: 2023年10月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- success rate of microcatheter induction
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- No limit 至 No limit（—）
入选标准
- •Patients who have undergone endovascular treatment using a CHIKAI neuroguidewire for stroke or aneurysm during the investigations period.
排除标准
- •Patients treated with unapproved medical devices.
结局指标
主要结局
success rate of microcatheter induction
Definition of successful induction: a successful induction is considered when any of the following (1) to (4) are met. (1) Was the microcatheter tip able to reach the aneurysm? (2) Was the microcatheter tip or the balloon portion of the balloon catheter able to reach the distal portion beyond the aneurysm? (iii) Was the tip of the microcatheter able to reach just before the site of occlusion or stenosis? (iv) Was the microcatheter tip able to reach the distal portion beyond the site of occlusion or stenosis?
次要结局
- Reach of the research device (guidewire) to the target site
- Need for replacement with other neuroguidewire
- Microcatheter or balloon catheter used in combination (product name)
- Failure during the procedure related to the research device
- Whether or not there are any adverse events that can not be ruled out as causally related to the research device
研究者
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