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After results of other studies published : EASY study became lapsed
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical treatment | Other | Conventional medical non-interventional treatment |
|
| Endovascular treatment | Other | Conventional medical treatment plus endovascular treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospitalization in specialized neuro-vascular unit | Other |
| ||
| Alteplase if patient is eligible |
| 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 |
| 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 |
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Inclusion Criteria:
AND one of the three following :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc-Antoine Labeyrie, MD | Hopital Lariboisiere, Paris | Principal Investigator |
| Michel Piotin, MD | Fondation Ophtalmologique Adolphe de Rothschild, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Henri Mondor | Créteil | 94010 | France | |||
| Fondation Ophtalmologique Adolphe de Rothschild |
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| Drug |
Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated) |
|
| Supportive care | Other | Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition |
|
| Endovascular treatment | Procedure | Recanalization treatment (thrombectomy / intraarterial thrombolysis) |
|
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 |
| Paris |
| 75019 |
| France |
| Hopital Foch | Suresnes | 92151 | France |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006760 | Hospitalization |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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