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临床试验/NCT03496064
NCT03496064已完成不适用

Bernese-European RegistrY for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE™ FR With the Intention For Thrombectomy

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2017年11月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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