CTRI/2021/07/034719已完成Unknown
Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated with Neurothrombectomy Devices in India
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- mTICI score
研究概览
简要总结
The purpose of this registry is to assess clinical outcomes and different factors that may affect these clinical outcomes that are associated with the use of Medtronic market-released neurothrombectomy devices SolitaireTM and/or ReactTM Aspiration catheters family of devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. A postâ€market registry designed to collect real world data associated with the use of Medtronic marketâ€released neurothrombectomy devices in acute ischemic stroke (AIS) patients from India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •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 marketâ€released neuro thrombectomy device as the initial device used to remove the thrombus 5.Subject is willing to participate in a 90â€day followâ€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.
排除标准
- •Patient must not meet any of the following general exclusion criteria:
- •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.
结局指标
主要结局
mTICI score
时间窗: Enrolment, Discharge and 90 days
NIHSS
时间窗: Enrolment, Discharge and 90 days
mRS score
时间窗: Enrolment, Discharge and 90 days
次要结局
- Cost effectiveness,(mRS, NIHSS)
研究者
研究点 (15)
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