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Clinical trial Recruiting at 3 sites Interventional Ages 18 to 84

Endovascular treatment for acute ischemic stroke caused by M2 segment blockage

Official title: Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery (the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-M2 Occlusion Trial: RESCUE-M2O Trial)

Run by Hyogo Medical University · NCT07347665 · Data updated 2026-11-12

This trial will test whether endovascular therapy helps adults (18–84) who have an acute ischemic stroke from a blockage in the M2 segment of the middle cerebral artery.

Quick facts

Study typeInterventional
Ages18 Years to 84 Years
SexAll
Enrollment200 (estimated)
SponsorHyogo Medical University
Academic / other
Locations3 sites (Nishinomiya, Hyōgo and 2 other locations)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedMarch 31, 2028
Study endsMarch 31, 2030
Registry record updatedJuly 17, 2026
Trial IDNCT07347665 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–84 with acute ischemic stroke due to an M2 MCA occlusion confirmed on angiography, NIHSS ≥ 8, ASPECTS ≥ 8, prestroke mRS 0–1, within 24 hours of last known well, and eligible for endovascular treatment are the intended participants.

Probably not a fit

Patients with multiple major intracranial occlusions, significant mass effect or midline shift, acute intracranial hemorrhage, severe contrast allergy, or anatomically inaccessible vessels are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RESCUE-M2O is a prospective, open-label, blinded-endpoint (PROBE) two-arm randomized controlled post-market trial comparing endovascular therapy to a control arm for acute ischemic stroke due to M2 occlusion. Eligible patients have angiographically confirmed M2 occlusion, NIHSS ≥ 8, ASPECTS or DWI-ASPECTS ≥ 8, prestroke mRS 0–1, and can be randomized within 24 hours of last known well. The protocol requires that endovascular therapy be initiated within 30 minutes of randomization when assigned to that arm. Safety and efficacy outcomes are adjudicated by blinded reviewers.

Why it matters

Potential benefit: If successful, this approach could increase the chance of meaningful recovery and reduce long-term disability for patients with M2 occlusion strokes.

How similar studies have gone: Endovascular therapy is proven for proximal large-vessel occlusions such as M1, but randomized evidence specifically for M2 occlusions is limited and remains an active area of study.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Hyogo Medical University
    Nishinomiya, Hyōgo, Japan     Recruiting
  • Thammasat University Hospital
    Khlong Luang, Changwat Pathum Thani, Thailand     Recruiting
  • S.I.S Can Tho International General Hospital
    Can Tho, Can Tho City, Vietnam     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.