Safety and efficacy of the stabilizer device using in endovascular therapy for cerebral aneurysm

sakai nobuyuki0 个研究点目标入组 5 人开始时间: 2021年10月4日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 5

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Primary endpoint, defined hemorrhagic complication, did not occur because the trial device was stable without unexpected movements. Secondary endpoint for safety, defined 1; ischemic stroke, 2; arterial dissection, 3; vasospasm, did not occur. 4; other adverse event, transient finger fine movement disturbance occurred just after treatment in 1 case, but disappeared spontaneously and no ischemic change on MRI at next day of treatment. This even is not related to device and treatment.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 <= 80age old（—）
性别: All

入选标准

•1)Patients who are scheduled to have a flow divertor or coil-assisted stent for cerebral aneurysm
•2) Patients who are expected to have difficulty delivering the catheter to the treatment site.
•3)Patients aged between 20years and 80years old at the time of concent acquisition
•4)Patients who consented to the study in writing

排除标准

•1)A history of hypersensitivity to nickel or titanium
•2)A patient who is judged by the principal investigator to be inappropriate in this study

研究者

发起方

sakai nobuyuki

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