NCT04162483Unknown不适用
Safety and Performance of the Neuroform Atlas™ Stent System in Patients Requiring Stent Assisted Intracranial Aneurysm Treatment in France - A National, Retrospective Multi-center Registry
Stryker Neurovascular1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2019年11月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- permanent morbidity and mortality rate
研究概览
简要总结
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.
详细描述
This proposed ATLAS FR study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in France between 01 February 2017 and 01 March 2018.
This will provide a comprehensive data set that is specifically representative of the Atlas stent use in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2
- •Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data
排除标准
- 未提供
结局指标
主要结局
permanent morbidity and mortality rate
时间窗: up to 12-16 months post-procedure
any major ipsilateral stroke or neurological death
次要结局
- Retreatment(up to 12-16 months)
- AEs and device malfunctions(peri-procedure)
- Subarachnoid hemorrhage (SAH)(Up to 12-16 months)
- Aneurysm rupture/re-rupture(Up to 12-16 months)
- SAEs resulting in neurological death(Up to 12-16 months)
- Efficacy Endpoint with mRS(immediately post-procedure and at 12-16 months post procedure)
- device-related SAEs(Up to 12-16 months)
研究者
研究点 (1)
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