Ireland
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Recruiting Not applicable

Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery

NCT07347665 · tracked via the Priya Life Science Japan tracker
Sponsor
Hyogo Medical University
Phase
Not applicable
Started
2025-12-01
Last updated
2026-07-17

Condition(s) studied

Endovascular TherapyAcute Ischemic StrokeAcute Ischemic Stroke (AIS) Related to a Distal Occlusion

Investigational drug(s) / intervention(s)

Endovascular therapy

Endovascular therapy: Endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
84 Years
Healthy volunteers
No
Inclusion Criteria: 1. Acute cerebral infarction 2. Aged 18-84 years 3. NIHSS score at admission ≥ 8 4. Prestroke mRS scores of 0-1 (able to carry out all usual activities) 5. Occlusion of the M2 segment of MCA on digital subtraction angiography 6. ASPECTS ≥ 8 or DWI-ASPECTS ≥ 8 7. Ineligible or failed intravenous tPA (no recanalization within 30 min after injection) 8. Randomization can be completed within 24 h from the last known well time 9. EVT can be initiated within 30 min from randomization. 10. The patient or their legally authorized representative has signed the informed consent form. Exclusion Criteria: 1. Occlusion of the anterior temporal artery, duplicate M1, or accessory M1 2. Occlusion of multiple major intracranial arteries 3. Difficulty in endovascular access due to tortuous vascular anatomy 4. Significant mass effect with midline shift on CT (or MRI) 5. Known allergy (more severe than skin rash) to contrast agents 6. Evidence of acute intracranial hemorrhage on CT (or MRI) 7. Pregnant or potentially pregnant 8. Clinical evidence of chronic occlusion 9. High risk of hemorrhage (platelet \< 40,000/ul, APTT \> 50 sec or PT-INR \> 3.0) 10. Participating in any other therapeutic investigational trial 11. Judgment of the investigator to be non-compliant or uncooperative during the study

Primary outcome measure(s)

  • Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2 — 90 days after randomization
    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.

Trial sites (3)

FacilityCityRegionStatus
Hyogo Medical University Nishinomiya Hyōgo Recruiting
Thammasat University Hospital Khlong Luang Changwat Pathum Thani Recruiting
S.I.S Can Tho International General Hospital Can Tho Can Tho City Recruiting

More Hyogo Medical University trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347665 on ClinicalTrials.gov ↗ ← All trials in Japan