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NCT Number: NCT07347665

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

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.

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Key information

Conditions

Endovascular Therapy Acute Ischemic Stroke Acute Ischemic Stroke (AIS) Related to a Distal Occlusion Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hyogo Medical University, Nishinomiya, Hyōgo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)
  • 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

Treatment and study plan

Endovascular therapy

Procedure

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

Primary outcomes

  1. Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2

    Time frame: 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.

Secondary outcomes

  1. Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-1

    Time frame: 90 days after randomization

  2. modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis

    Time frame: 90 days after randomization

  3. National Institutes of Health Stroke Scale (NIHSS; range, 0-42; higher scores indicate more severe neurological impairment) improvement of 8 points or more

    Time frame: 48 hours after randomization

  4. Health-related quality of life assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L; range, 0-1.0; higher scores indicating better health-related quality of life)

    Time frame: 90 days after randomization

  5. Symptomatic intracranial hemorrhage

    Time frame: 48 hours after randomization

  6. Any intracranial hemorrhage

    Time frame: 48 hours after randomization

  7. All cause death

    Time frame: 90 days after randomization

  8. Recurrence of cerebral infarction

    Time frame: 90 days after randomization

  9. Decompressive craniectomy

    Time frame: 7 days after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Kazutaka Uchida, MD, PhD

CONTACT

[email protected]

81+798-45-6458

Sponsors and collaborators

Lead sponsor

Hyogo Medical University

Other

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jan 16, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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