NCT03504436已完成不适用
Evaluation of the LEO + Stent in the Endovascular Treatment of Wide Neck Intracranial Aneurysms (Fusiform, Saccular or Dissecting), Ruptured or Not Ruptured: Cohort of the Self-expanding Intracranial Stent LEO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 主要终点
- Total aneurysmal occlusion rate
研究概览
简要总结
This is a prospective, multicenter, single-arm observational study to evaluate the efficacy and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform, saccular or dissecting), ruptured or not ruptured.
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
- •All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent
- •Patients (or their parents for minors) must be informed and give written consent
排除标准
- •Patients (or parents) who refused to give consent.
结局指标
主要结局
Total aneurysmal occlusion rate
时间窗: 18 months
Classification of the occlusion observed angiographically as "complete occlusion", "residual neck" or "residual aneurysm" using the Montreal three-grade scale
Morbi-mortality
时间窗: 18 months
Number of complications and/or device or procedure related adverse events
次要结局
未报告次要终点
研究者
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