NCT04315168已完成不适用
Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment
Microvention-Terumo, Inc.1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Mortality Rate
研究概览
简要总结
A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms
详细描述
Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.
Sample Size: 138 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR
- •Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
排除标准
- 未提供
结局指标
主要结局
Mortality Rate
时间窗: 1 year
Percentage of patients with neurological death
Morbidity Rate
时间窗: 1 year
Percentage of patients with major ipsilateral stroke
次要结局
- modified Rankin Score(1 year)
- Complete aneurysm occlusion rate(1 year)
- Retreatment Rate(1 year)
- Patient description(1 year)
研究者
研究点 (1)
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