A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Effectiveness
研究概览
简要总结
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
详细描述
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
The study design is an interventional, prospective, single-arm, open label clinical trial.
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
- •The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented
- •Age >18 years
- •Clinical signs consistent with an acute ischemic stroke
- •Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
- •Pre-stroke modified Rankin Score (mRS) <= 2
- •Acute occlusion of the M1 segment of the middle cerebral artery (MCA), internal carotid artery (ICA), vertebral or basilar arteries confirmed via computed tomography angiography (CTA) and/or magnetic resonance angiography (MRA)
- •The Investigator estimates that at least one delivery of the Route 92 Medical Reperfusion System can be completed within 24 hours of time last known well
- •In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit
- •Angiographic confirmation of an occlusion of the M1 segment* of the middle cerebral artery, internal carotid artery, vertebral or basilar arteries with a modified Thrombolysis In Cerebral Infarction (mTICI) scale score of 0-1
排除标准
- •Known pregnancy or breast feeding
- •Known comorbidity that may complicate treatment or prevent improvement or follow-up
- •Known life expectancy < 12 months
- •Known history of severe allergy to contrast medium
- •Subject known to have suffered a stroke in the past 90 days
- •Subject participating in another study involving an investigational device or drug.
- •Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers-Danlos syndrome)
- •Any known pre-existing hemorrhagic or coagulation deficiency
- •Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage
- •Baseline CT or MRI showing intracranial tumor (except small meningioma)
- •Angiographic evidence of dissection in the extracranial or intracranial arteries
- •Angiographic evidence of carotid dissection
- •Angiographic evidence of multiple vascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation). Note: tandem occlusions may be included at the discretion of the operating physician.
结局指标
主要结局
Effectiveness
时间窗: Procedure
The primary effectiveness endpoint is arterial revascularization as measured by a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments.
Device-related peri-procedural complications
时间窗: Procedure
dissection or perforation
Symptomatic Intracranial Cerebral Hemorrhage (SICH)
时间窗: 24 hour
defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale \[NIHSS\] score of \>=4 points
Embolization to a previously uninvolved territory
时间窗: Procedure
Embolization to a previously uninvolved territory
次要结局
- NIHSS score(24 hours after treatment)
- Modified Rankin Score(90 days after treatment)
- Procedure Time(Procedure)
- Procedure-Related SAEs(Procedure)