Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Efficacy Evaluation
研究概览
简要总结
PRAAN is a post-market registry designed to collect real-world data associated with the use of Medtronic market release neurothrombectomy devices in acute ischemic stroke (AIS) patients from India.
详细描述
The objective of this registry is to access clinical outcomes associated with the use of these device in patients experiencing the AIS due to large intracranial vessel occlusion within 8 hours of last known well.
Real-world evidence per Standard-of-care (SOC) will be generated using Medtronic neurothrombectomy devices approved in India, using on-label indications for use in this post-market clinical follow-up registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
- •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), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries
- •Subject has been or will be treated with a Medtronic market-released neuro thrombectomy device as the initial device used to remove the thrombus
- •Subject is willing to participate in a 90-day follow-up visit
- •Treatment within 24 hours of last known well. For subjects with stroke onset >6 hours:
- •ASPECTS score >5 (per DW-MRI) or >6 (per NCCT)
- •NCCT Core Infarct < 70 ml or MRI DWI with < 70 ml core volume or CTP Ratio of volume of ischemic tissue (penumbra) to infarction of ≥1.8 and an absolute volume of potentially reversible ischemia of ≥15ml
- •Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
- •Pre-treatment National Institutes of Health Stroke Scale (NIHSS)
- •≥6 and ≤30 for patients with ≤6 hours of stroke onset.
- •≥10 and ≤30 for patients with >6 hours of stroke onset.
排除标准
- •Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis
- •Patients meeting the contraindication as mentioned in the IFU of devices.
- •Significant mass effect with midline shift
结局指标
主要结局
Efficacy Evaluation
时间窗: Day 7/Discharge after the procedure & 3 month after the procedure
1. NIHSS at day 7 or discharge, whichever comes first 2. mRS at discharge or day 7 3. mRS and NIHSS score at 90 days post index stroke procedure
Safety Evaluation
时间窗: from index procedure till 3 month after the procedure performed
Incidence of Neurological Events of Interest, All-cause mortality, Procedure-related AEs, Device-related AEs, and all SAEs
Performance Evaluation
时间窗: During the Procedure
Time to revascularization and revascularization assessment at the end of the procedure using mTICI score
次要结局
- Health Economic analysis of neurothrombectomy procedure in the treatment of patients suffering with ACUTE ISCHEMIC STROKE(At subject discharge after the procedure and 3 month after the procedure)