About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute cerebral infarction
Aged 18-84 years
NIHSS score at admission ≥ 8
Prestroke mRS scores of 0-1 (able to carry out all usual activities)
Disqualifiers
Occlusion of the anterior temporal artery, duplicate M1, or accessory M1
Occlusion of multiple major intracranial arteries
Difficulty in endovascular access due to tortuous vascular anatomy
Significant mass effect with midline shift on CT (or MRI)
Trial design
Parallel
Treatments tested in this trial
Endovascular therapy
Procedure/SurgeryEndovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-1
modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis
National Institutes of Health Stroke Scale (NIHSS; range, 0-42; higher scores indicate more severe neurological impairment) improvement of 8 points or more
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)
Sponsors and contacts
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