Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Evaluate technical efficacy outcomes with radiographical measurements
研究概览
简要总结
The Jacobs Institute is participating in a Sponsor Investigator study designed to collect prospective clinical evidence to evaluate the use of a neurological thrombectomy device for clot retrieval in acute ischemic patients
详细描述
The neurological thrombectomy device is an investigational device
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •at least 18 years of age at time of consent Has baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 8; Able to be treated within 8 hours of stroke symptom onset or Last Known Normal (LKN);
排除标准
- •Cannot provide consent or legally authorized representative not available to provide consent
结局指标
主要结局
Evaluate technical efficacy outcomes with radiographical measurements
时间窗: Day 1
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
outcomes with radiographical measurements
时间窗: day 1
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
次要结局
- Evaluate technical efficacy outcomes with radiographical measurements(90 days)
研究者
Adnan Siddiqui
Principal Investigator
Jacobs institute