NCT07347665

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Dec 2025Mar 2030

Study Start

First participant enrolled

December 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

January 9, 2026

Last Update Submit

February 22, 2026

Conditions

Acute Ischemic Stroke (AIS) Related to a Distal OcclusionEndovascular TherapyAcute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

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

    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.

    90 days after randomization

Secondary Outcomes (9)

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

    90 days after randomization

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

    90 days after randomization

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

    48 hours after randomization

  • 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)

    90 days after randomization

  • Symptomatic intracranial hemorrhage

    48 hours after randomization

  • +4 more secondary outcomes

Study Arms (2)

Medical therapy with endovascular therapy

EXPERIMENTAL
Procedure: Endovascular therapy

Medical therapy alone

NO INTERVENTION

Interventions

Endovascular therapyPROCEDURE

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

Medical therapy with endovascular therapy

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hyogo Medical University

Nishinomiya, Hyōgo, 663-8501, Japan

NOT YET RECRUITING

Hyogo Medical University

Nishinomiya, Hyōgo, 663-8501, Japan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Kazutaka Uchida, MD, PhD

CONTACT

81+798-45-6458fu-sakakibara@hyo-med.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Stroke Center)

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2030

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

JP(2)