Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the… (NCT07347665) | Clinical Trial Compass
RecruitingNot Applicable
Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery
Japan200 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range18 Years – 84 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Occlusion of the M2 segment of MCA on digital subtraction angiography
✓. ASPECTS ≥ 8 or DWI-ASPECTS ≥ 8
✓. Ineligible or failed intravenous tPA (no recanalization within 30 min after injection)
✓. Randomization can be completed within 24 h from the last known well time
Exclusion criteria
✕. 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)
✕. Known allergy (more severe than skin rash) to contrast agents
✕. Evidence of acute intracranial hemorrhage on CT (or MRI)
What they're measuring
1
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2