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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
Recanalization treatment (thrombectomy / intraarterial thrombolysis)
Hopital Henri Mondor
Créteil, France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France
Hopital Foch
Suresnes, France
Improvement in NIHSS score after 24h
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)
Time frame: 24 hours
Improvement in NIHSS score after 7 days
Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and day7 (t2) calculated as follow : \[NIHSS(t0) - NIHSS(t2)\] / NIHSS(t0)
Time frame: 7 days
Functional recovery after 3 months
modified Rankin Score (mRS) after 3 months ("positive recovery" if mRS \<=2, "excellent recovery" if mRS\<=1)
Time frame: 3 months
Fatality within 7 days
Proportion of patients deceased within seven days after stroke
Time frame: 7 days
Fatality within 3 months
Proportion of patients deceased within 3 months after stroke
Time frame: 3 months
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