Endovascular treatment for acute ischemic stroke caused by M2 segment blockage

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)

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 84 Years
• Sex: All
• Sponsor: Hyogo Medical University (Academic / other)
• Locations: 2 sites (Nishinomiya, Hyōgo and 1 other locations)
• Trial ID: NCT07347665 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Nishinomiya, Hyōgo and 1 other locations

• Hyogo Medical University — Nishinomiya, Hyōgo, Japan (Not_yet_recruiting)
• Hyogo Medical University — Nishinomiya, Hyōgo, Japan (Recruiting)

Study contacts

• Study coordinator: Kazutaka Uchida, MD, PhD

Conditions Endovascular Therapy; Acute Ischemic Stroke; Acute Ischemic Stroke Related to a Distal Occlusion