JPRN-jRCTs052210098
已完成
未知
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2021年10月4日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- cerebral aneurysm
- 发起方
- sakai nobuyuki
- 入组人数
- 5
- 状态
- 已完成
- 最后更新
- 2年前
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.
研究者
入排标准
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
结局指标
主要结局
未指定
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