NCT02982200终止不适用
The MEDINA Study: Medina Embolization Device In Neurovascular Aneurysms Study - A Post Market Clinical Follow-up Study
Medtronic Neurovascular Clinical Affairs3 个研究点 分布在 3 个国家目标入组 15 人开始时间: 2016年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC)
研究概览
简要总结
A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent using the Ethics Committee-approved consent form and agrees to comply with protocol requirements
- •Subject is 18- 85 years old
- •Subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the Medina Embolization Device
排除标准
- •Aneurysm is partially thrombosed
- •Aneurysm has been previously treated with surgery or endovascular therapy
- •Subject has had major brain surgery including endovascular procedures within the past 30 days
- •Vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm
- •Subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation
- •The Investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment
结局指标
主要结局
Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC)
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (3)
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