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This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVT | Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated |
| |
| IVT + EVT | Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset |
| |
| IVT (intravenous thrombolytic therapy) | Patients that will received IVT only within 4.5 hours after onset |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVT (endovascular treatment ) | Procedure |
| ||
| IVT (intravenous thrombolytic therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Death within 90 days after onset | 90 days | |
| Symptomatic intracranial haemorrhage | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke recovery rate after discharge | Recovery defined as a 10-fold decrease in NIHSS or NIHSS (7 days after onset or at discharge) | From onset to discharge |
| Functional recovery | Modified Rankin Score (RMS) value |
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Inclusion Criteria:
Exclusion Criteria:
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Patients younger than 80 with acute ischemic stroke produced by a main artery oclussion with a NIHSS > 6 (National Institute of Health Stroke Scale) receiving IVT or EVT within 4.5 hours after onset.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gregorio Marañón | Madrid | Madrid | 28007 | Spain | ||
| Hospital Universitario RamĂłn y Cajal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27821473 | Derived | Alonso de Lecinana M, Martinez-Sanchez P, Garcia-Pastor A, Kawiorski MM, Calleja P, Sanz-Cuesta BE, Diaz-Otero F, Frutos R, Sierra-Hidalgo F, Ruiz-Ares G, Fandino E, Diez-Tejedor E, Gil-Nunez A, Fuentes B. Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis: a prospective observational study. J Neurointerv Surg. 2017 Nov;9(11):1041-1046. doi: 10.1136/neurintsurg-2016-012727. Epub 2016 Nov 7. | |
| 26838587 |
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| Procedure |
|
| 4.5 hours after onset |
| Madrid |
| Madrid |
| 28034 |
| Spain |
| Hospital ClĂnico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario Doce de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Derived |
| Kawiorski MM, Martinez-Sanchez P, Garcia-Pastor A, Calleja P, Fuentes B, Sanz-Cuesta BE, Lourido D, Marin B, Diaz-Otero F, Vicente A, Sierra-Hidalgo F, Ruiz-Ares G, Diez-Tejedor E, Fandino E, Alonso de Lecinana M. Alberta Stroke Program Early CT Score applied to CT angiography source images is a strong predictor of futile recanalization in acute ischemic stroke. Neuroradiology. 2016 May;58(5):487-93. doi: 10.1007/s00234-016-1652-7. Epub 2016 Feb 2. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| 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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