A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPointTM Reperfusion SystemTM for Aspiration Embolectomy in Acute Ischemic Stroke Patients

Route 92 Medical, Inc.0 个研究点目标入组 15 人开始时间: 2019年6月26日最近更新: 2020年3月3日

适应症

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•1.The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented
•2.Age >=18 years
•3.Clinical signs consistent with an acute ischemic stroke
•4.Baseline National Institutes of Health Stroke Scale (NIHSS) score ? 6
•5.Pre-stroke modified Rankin Score (mRS) ? 2
•6.Acute occlusion 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)
•7.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
•8.In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit
•9.Angiographic confirmation of an occlusion or near occlusion 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

•1.Known pregnancy or breast feeding
•2.Known comorbidity that may complicate treatment or prevent improvement or follow-up
•3.Known life expectancy < 12 months
•4.Known history of severe allergy to contrast medium
•5.Subject known to have suffered a stroke in the past 90 days
•6.Subject participating in another study involving an investigational device or drug.
•7.Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers-Danlos syndrome)
•8.Any known pre-existing hemorrhagic or coagulation deficiency
•9.Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage
•10.Baseline CT or MRI showing intracranial tumor (except small meningioma)
•11.Angiographic evidence of dissection in the extracranial or intracranial arteries
•12.Angiographic evidence of carotid dissection
•13.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.

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