NCT01006993已完成1 期
Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA
CoAxia8 个研究点 分布在 2 个国家目标入组 22 人开始时间: 2007年5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
- 22
- 试验地点
- 8
- 主要终点
- An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.
研究概览
简要总结
To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.
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
- •Ischemic stroke
- •NIHSS between 5-22
- •Persistent clinical deficits following administration of rt-PA
排除标准
- •Planned thrombectomy
- •Aortic pathology
- •Severe heart disease
- •Other conditions the doctor will assess
结局指标
主要结局
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.
时间窗: Baseline to 30 days post-treatment
次要结局
- Potential patient benefit will be assessed through collection of neurological indices.(Baseline through 90 days)
研究者
研究点 (8)
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