Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- First Pass Reperfusion Effect (FPE)
研究概览
简要总结
A Feasibility Study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO).
详细描述
The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age 18 years or older
- •Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours
- •Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
排除标准
- •Evidence of hemorrhage
- •Significant mass effect and/or midline shift
- •Vessel tortuosity too difficult to allow endovascular access per investigator judgment
- •Severe or fatal co-morbidities
结局指标
主要结局
First Pass Reperfusion Effect (FPE)
时间窗: Intra-procedural
Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel
次要结局
- All cause mortality rate(90 days)
- Frontline technical success(Intra-procedural)
- Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure(90 days)
- Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure(24 hours)