Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: Hospitalization in specialized neuro-vascular unit
* Drug: Alteplase if patient is eligible
* Other: Supportive care
* Procedure: Endovascular treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Medical treatment<br>Conventional medical non-interventional treatment | Other: Hospitalization in specialized neuro-vascular unit<br> <br> Drug: Alteplase if patient is eligible<br>* Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)<br>Other: Supportive care<br>* Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition<br>|
| Other: Endovascular treatment<br>Conventional medical treatment plus endovascular treatment | Other: Hospitalization in specialized neuro-vascular unit<br> <br> Drug: Alteplase if patient is eligible<br>* Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)<br>Other: Supportive care<br>* Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition<br>Procedure: Endovascular treatment<br>* Recanalization treatment (thrombectomy / intraarterial thrombolysis)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 7 days | 
| Functional recovery after 3 months | modified Rankin Score (mRS) after 3 months (positive recovery if mRS <=2, excellent recovery if mRS<=1) | 3 months | 
| Fatality within 7 days | Proportion of patients deceased within seven days after stroke | 7 days | 
| Fatality within 3 months | Proportion of patients deceased within 3 months after stroke | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Endovascular treatment, Tandem carotid occlusions, Fibrinolysis