Bernese-European RegistrY for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE™ FR With the Intention For Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- 3 month functional independence
研究概览
简要总结
The Bernese-European RegistrY for ischemic stroke patients treated Outside current guidelines with Neurothrombectomy Devices using the SOLITAIRE™ FR With the Intention For Thrombectomy (BEYOND-SWIFT) is a retrospective, multi-center, non-randomized observational study aims to investigate the safety and efficacy of a Medtronic market-released neurothrombectomy device (applied as initial devices used for intervention) in acute ischemic stroke patients who do not fulfill treatment eligibility according to current guidelines. Patients will be treated or were treated at the discretion of the investigator, independent of participation in this registry. Primary Analysis is the Impact of successful reperfusion on functional outcome at day 90 in patients presenting with large infarct cores (ASPECTS<6) or minor symptoms (NIHSS<8).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients or patient's legally authorized representative have given informed consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies.
- •The patient presents with an intracranial large vessel occlusion and therewith-related neurological symptoms and has been or will be treated with a Medtronic marketed-release neurothrombectomy device (applied as first device to attempt retrieving the thrombus).
排除标准
- •Current participation in another clinical trial
结局指标
主要结局
3 month functional independence
时间窗: 0-90 days
Number of patients with modified Rankin Scale \<=2
Favourable outcome
时间窗: 0-90 days
Number of patients with modified Rankin Scale \<=3
Excellent outcome
时间窗: 0-90 days
Number of patients with modified Rankin Scale \<=1
次要结局
- Time to reperfusion(Day 0)
- Mortality(Day 0-90)
- Successful reperfusion(Day 0)
- Symptomatic intracranial hemorrhage(Day 0-1)
