The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 58
- 主要终点
- Rate of First Pass Reperfusion Effect (FPE)
研究概览
简要总结
The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.
详细描述
The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
- •Able to be treated within 8 hours of symptom onset or last known normal (LKN)
- •Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
- •Pre-morbid Modified Rankin Scale (mRS) score 0-1
- •Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
- •Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)
排除标准
- •Intracranial Hemorrhage (ICH)
- •Alberta Stroke Program Early CT Score (ASPECTS) <6
- •Intracranial Atherosclerotic Disease (ICAD)
- •Multiple or tandem occlusions
- •Life expectancy less than 6 months
研究组 & 干预措施
Treatment Arm
Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.
干预措施: RapidPulseTM Aspiration System (Device)
结局指标
主要结局
Rate of First Pass Reperfusion Effect (FPE)
时间窗: Intra-procedural
The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass
Rate of symptomatic intracranial hemorrhage (sICH)
时间窗: Post-procedural (24 hours post-thrombectomy)
The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy
次要结局
- Rate of reperfusion after all study device passes(Intra-procedural)
- Modified Rankin Scale (mRS) at 90 days post treatment(Post-procedure (90 days post-thrombectomy))