The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Modified Rankin Score (mRs )
研究概览
简要总结
THRACE is a controled, multicenter and randomized trial.
The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale [NIHSS] ≥ 10).
The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10<=NIHSS Score=<25
- •Symptoms onset less than 4 hours
- •Occlusion of the intracranial carotid, the middle cerebral artery (M1) or the upper third of the basilar
排除标准
- •Contraindications for intravenous thrombolysis
- •Occlusion or stenosis of the pre-occlusive cervical internal carotid artery ipsilateral to the lesion
- •Any cause local prohibiting femoral catheterization
研究组 & 干预措施
IV thrombolysis + thrombectomy
干预措施: Alteplase (rt-PA)/Actilyse (Drug)
IV thrombolysis + thrombectomy
干预措施: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE) (Procedure)
IV thrombolysis
干预措施: Alteplase (rt-PA)/Actilyse (Drug)
结局指标
主要结局
Modified Rankin Score (mRs )
时间窗: 3 months after treatment
次要结局
- Quality of Life (Euroqol EQ-5D)(3 months after treatment)
- Barthel Score(3 months after treatment)
研究者
Directeur de la Recherche et de l'Innovation
Professor Serge BRACARD
Central Hospital, Nancy, France