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RESCUE-M2O trial is a prospective, open label, blinded endpoint (PROBE), two-arm, randomized, controlled, post-market study to assess the efficacy and safety of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical therapy with endovascular therapy | Experimental |
| |
| Medical therapy alone | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular therapy | Procedure | Endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2 | modified Rankin Scale (mRS) is an ordinal scale ranging from 0 (no symptoms) to 6 (death) measuring the degree of disability or dependence in everyday life. | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-1 | 90 days after randomization | |
| modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis | 90 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kazutaka Uchida, MD, PhD | Contact | 81+798-45-6458 | fu-sakakibara@hyo-med.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyogo Medical University | Not yet recruiting | Nishinomiya | Hyōgo | 663-8501 | Japan | |
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| National Institutes of Health Stroke Scale (NIHSS; range, 0-42; higher scores indicate more severe neurological impairment) improvement of 8 points or more | 48 hours after randomization |
| Health-related quality of life assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L; range, 0-1.0; higher scores indicating better health-related quality of life) | 90 days after randomization |
| Symptomatic intracranial hemorrhage | 48 hours after randomization |
| Any intracranial hemorrhage | 48 hours after randomization |
| All cause death | 90 days after randomization |
| Recurrence of cerebral infarction | 90 days after randomization |
| Decompressive craniectomy | 7 days after randomization |
| Hyogo Medical University |
| Recruiting |
| Nishinomiya |
| Hyōgo |
| 663-8501 |
| Japan |
|
| 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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