Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated with Neurothrombectomy Devices in India - PRAA

India Medtronic Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年5月27日

研究概览

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•1. Subject/subject’s legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
•2.Subject is 18 years of age or older
•3. Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel
•occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries
•4.Subject has been or will be treated with a Medtronic market ?released neuro thrombectomy
•device as the initial device used to remove the thrombus
•5.Subject is willing to participate in a 90 ?day follow ?up visit
•6.Treatment within 8 hours of last known well
•7.Pre-Stroke Modified Rankin Scale (mRS) score =1 (immediately) prior to stroke onset
•8.Pre-treatment National Institutes of Health Stroke Scale (NIHSS) = 6 and = 30

•Patient must not meet any of the following general exclusion criteria:
•1. Concurrent participation in another mechanical neuro thrombectomy device trial or any other
•clinical trial with an active treatment arm or where the study procedure or treatment might
•confound the study analysis
•2.Patients meeting the contraindication as mention in the IFU of devices
•3.Patients identified with active COVID-19 infection at the time of enrollment

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