NCT01404403已完成1 期
Safety Study of the Rapid System for Acute Ischemic Stroke
Rapid Medical2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage
研究概览
简要总结
This is a safety study of the Rapid System for acute ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 to <85 years old
- •Pre stroke modified Rankin Scale (mRS) of ≤2
- •A signed informed consent by patient or a legally acceptable representative
排除标准
- •Pre-stroke life expectancy of less than 6 months
- •Current participation in another investigational drug or device study
- •Pregnancy
结局指标
主要结局
Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage
时间窗: 12 patients
次要结局
未报告次要终点
研究者
研究点 (2)
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