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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Hyogo Medical University
Nishinomiya, Hyōgo, Japan
NOT_YET_RECRUITINGHyogo Medical University
Nishinomiya, Hyōgo, Japan
RECRUITINGAchievement 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.
Time frame: 90 days after randomization
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-1
Time frame: 90 days after randomization
modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis
Time frame: 90 days after randomization
National Institutes of Health Stroke Scale (NIHSS; range, 0-42; higher scores indicate more severe neurological impairment) improvement of 8 points or more
Time frame: 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)
Time frame: 90 days after randomization
Symptomatic intracranial hemorrhage
Time frame: 48 hours after randomization
Any intracranial hemorrhage
Time frame: 48 hours after randomization
All cause death
Time frame: 90 days after randomization
Recurrence of cerebral infarction
Time frame: 90 days after randomization
Decompressive craniectomy
Time frame: 7 days after randomization
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