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

Recruiting now · Not applicable

Conditions studied: Endovascular Therapy, Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

In brief

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.

Key facts

Study ID

NCT07347665

Run by

Hyogo Medical University

People needed

200

Starts

2025-12-01

Expected to finish

2030-03-31

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• EVT can be initiated within 30 min from randomization.
• The patient or their legally authorized representative has signed the informed consent form.

You may not qualify if…

• 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)
• Pregnant or potentially pregnant
• Clinical evidence of chronic occlusion
• High risk of hemorrhage (platelet < 40,000/ul, APTT > 50 sec or PT-INR > 3.0)
• Participating in any other therapeutic investigational trial
• Judgment of the investigator to be non-compliant or uncooperative during the study

Where it is running

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

Full record on ClinicalTrials.gov

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