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

NCT ID: NCT07347665

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2030-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endovascular Therapy Acute Ischemic Stroke Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medical therapy with endovascular therapy

Group Type EXPERIMENTAL

Endovascular therapy

Intervention Type PROCEDURE

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

Medical therapy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endovascular therapy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hyogo Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kazutaka Uchida

Associate Professor (Stroke Center)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hyogo Medical University

Nishinomiya, Hyōgo, Japan

Site Status NOT_YET_RECRUITING

Hyogo Medical University

Nishinomiya, Hyōgo, Japan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kazutaka Uchida, MD, PhD

Role: CONTACT

81+798-45-6458

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kazutaka Uchida, MD, PhD

Role: primary

+81-798-45-6458

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R000066936

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MLC1501 Study Assessing Efficacy in STROke Recovery
NCT05046106 NOT_YET_RECRUITING PHASE2/PHASE3