Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Improvement in NIHSS score after 24h
研究概览
简要总结
This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.
The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.
The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone
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
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologically proven acute proximal occlusion of middle cerebral artery
- •AND one of the three following :
- •tandem internal carotid / middle cerebral artery occlusion
- •intravenous thrombolysis contraindicated because of high risk of haemorrhage
- •intravenous thrombolysis not possible because of delay > 4.5 hours
排除标准
- •Impossibility to perform endovascular recanalization within 6h
- •Clinically minor stroke (NIHSS score below 5 at baseline)
- •Extended cerebral infarction
- •Severe comorbidity
- •Life expectancy below 3 months before stroke
- •Pregnancy or breastfeeding
- •modified Rankin Score superior to 2 before stroke
研究组 & 干预措施
Medical treatment
Conventional medical non-interventional treatment
干预措施: Hospitalization in specialized neuro-vascular unit (Other)
Medical treatment
Conventional medical non-interventional treatment
干预措施: Alteplase if patient is eligible (Drug)
Medical treatment
Conventional medical non-interventional treatment
干预措施: Supportive care (Other)
Endovascular treatment
Conventional medical treatment plus endovascular treatment
干预措施: Hospitalization in specialized neuro-vascular unit (Other)
Endovascular treatment
Conventional medical treatment plus endovascular treatment
干预措施: Alteplase if patient is eligible (Drug)
Endovascular treatment
Conventional medical treatment plus endovascular treatment
干预措施: Supportive care (Other)
Endovascular treatment
Conventional medical treatment plus endovascular treatment
干预措施: Endovascular treatment (Procedure)
结局指标
主要结局
Improvement in NIHSS score after 24h
时间窗: 24 hours
Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow : \[NIHSS(t0) - NIHSS(t1)\] / NIHSS(t0)
次要结局
- Improvement in NIHSS score after 7 days(7 days)
- Fatality within 7 days(7 days)
- Functional recovery after 3 months(3 months)
- Fatality within 3 months(3 months)