Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Probable benefit
研究概览
简要总结
An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms.
The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.
详细描述
Patients will be treated with the Nautilus, then will be followed up for up to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Patients who present with intracranial aneurysm
排除标准
- •* Unstable neurological deficit
结局指标
主要结局
Probable benefit
时间窗: 3-6 months
Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up
Serious Adverse Events
时间窗: 3-6 months
The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up
次要结局
未报告次要终点