Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia (PROSPR-SEA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 10
- 主要终点
- Modified Rankin Scale (mRS) at 90 Days
研究概览
简要总结
The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.
详细描述
This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements.
- •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 neurothrombectomy device as the initial device used to remove the thrombus.
- •Subject is willing to participate in a 90-day follow-up visit.
- •Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).
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.
结局指标
主要结局
Modified Rankin Scale (mRS) at 90 Days
时间窗: 90 Days Post Procedure
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
次要结局
- Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure(24 hrs ± 8 hrs post procedure)
- Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure(24 hrs ± 8 hrs post procedure)
- All-Cause Mortality Through 90 Days Post Procedure(90 Days Post Procedure)