PULSE-C: Early 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
- 19
- 试验地点
- 2
- 主要终点
- First Pass Reperfusion Effect (FPE)
研究概览
简要总结
The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).
详细描述
The purpose of this prospective, multi-center, open label study of the RapidPulseTM Aspiration System is to assess the initial technical (performance), effectiveness and safety of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The target sample size is 10 evaluable subjects with a maximum of 50 subjects. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge. The primary endpoint is first pass reperfusion effect (FPE) as defined by mTICI ≥ 2c after one reperfusion attempt.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours.
- •CTA, MRA or DSA demonstrating anterior large vessel occlusion involving the intracranial ICA, MCA M1 or M2 segments, basilar or vertebral artery
- •Target occlusion can be accessed by the RapidPulseTM 071 aspiration catheter assessed at the time of the index procedure. Enrollment will be defined by the successful navigation of the RapidPulseTM 071 aspiration catheter into the occlusion site.
排除标准
- •Known or suspected ICAD
- •Tandem occlusions
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
First Pass Reperfusion Effect (FPE)
时间窗: Intra-procedural
The number of subjects with mTICI ≥ 2c after one reperfusion attempt
次要结局
未报告次要终点