jRCT1032240363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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 18age old over 至 No limit（—）
入选标准
- •Patients who have undergone endovascular treatment using a neuroguidewire for ischemic stroke or cerebral aneurysm from January 1, 2022 to the date of Ethics Committee approval.
- •Patients who have given consent for the use of their medical information.
排除标准
- •Patients who used medical devices not approved in Japan
- •Patients under 18 years of age and those who need to obtain consent from a substitute
- •Patients whom the principal investigator considers to be unjustified as research subjects.
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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