NCT01133223撤回2 期
Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Functional independence (modified Rankin Scale 0-2)
研究概览
简要总结
Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient enrolled in acute ischemic stroke protocol
- •Up to 3,5h from symptoms onset
- •Clinical findings compatible with middle cerebral artery syndrome
- •Angiotomographic evidence of proximal middle cerebral artery occlusion
排除标准
- •NIHSS < 10
- •Overt contraindication to thrombolysis or angiopgraphy
- •Disagreement with informed consent term or refusal to participate
研究组 & 干预措施
Thrombectomy
Active Comparator
干预措施: Penumbra™ System (Device)
Usual Care
Active Comparator
干预措施: Recombinant tissue plasminogen activator (Drug)
结局指标
主要结局
Functional independence (modified Rankin Scale 0-2)
时间窗: 3 months
次要结局
- Minimal or no disability (modified Rankin Scale 0-1)(3 months)
- Overall mortality(7 days and 3 months)
- Symptomatic cerebral bleeding rate(48 hours, 7 days and 3 months)
研究者
Lucas Scotta Cabral
Lucas Scotta Cabral
Hospital de Clinicas de Porto Alegre
研究点 (1)
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