Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 515
- 试验地点
- 126
- 主要终点
- The safety of the NeuroFlo device and procedure will be compared to medical management alone
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.
详细描述
The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters:
- National Institute of Health Stroke Scale (NIHSS) at baseline (stratify <10, 11-18)
- Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify <5 hrs, or ≥5 hrs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Ischemic stroke
- •NIHSS between 5-18
- •Time from symptom onset less than 14 hours
排除标准
- •Hemorrhagic stroke
- •Certain types of heart disease
- •Kidney disease
- •Other conditions the doctor will assess
研究组 & 干预措施
1
干预措施: NeuroFlo™ catheter (Device)
2
干预措施: Control (Other)
结局指标
主要结局
The safety of the NeuroFlo device and procedure will be compared to medical management alone
时间窗: 90 days
Efficacy will be assessed using a global outcome score
时间窗: 90 days
次要结局
- Acute improvement in neurological function(24 hours)
- Hospital length of stay(Varies)
- Stroke Impact Scale(30 & 90 days)
- Patient disposition upon discharge will be compared(Varies)