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

Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke with Occlusion of the M2 Segment of Middle Cerebral Artery - RESCUE-M2O

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058537

Enrollment

200

Registered

2025-10-01

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke with Occlusion of the M2 Segment of Middle Cerebral Artery

Interventions

Medical therapy+Endovascular therapy Medical therapy alone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Acute cerebral infarction (2) Aged 18-84 years (3) NIHSS score at admission 8 or more (4) Prestroke mRS scores of 0-1 (5) Occlusion of the M2 segment of MCA on digital subtraction angiography (DSA) (6) ASPECTS 8 or more, or DWI-ASPECTS 8 or more (7) Ineligible or failed IV-tPA (no recanalization within 30 minutes after injection) (8) Randomization can be completed within 24 hours from the last known well time. (9) EVT can be initiated within 30 minutes from randomization. (10) The patient or their legally authorized representative has signed the informed consent form.

Exclusion criteria

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 second 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

Design outcomes

Primary

Measure	Time frame
Achievement of mRS scores of 0-2 at 90 days after randomization	—

Secondary

Measure	Time frame
(1) Achievement of mRS scores of 0-1 at 90 days after randomization (2) mRS shift analysis at 90 days after randomization (3) NIHSS improvement of 8 points or more at 48 hours after randomization (4) QOL (EQ-5D-3L) at 90 days after randomization (5) Symptomatic intracranial hemorrhage (ICH) within 48 hours after randomization (6) Any ICH within 48 hours after randomization (7) All cause death (mRS 6) within 90 days after randomization (8) Recurrence of cerebral infarction within 90 days after randomization (9) Decompressive craniectomy within 7 days after randomization	—

Measure

Time frame

(1) Achievement of mRS scores of 0-1 at 90 days after randomization (2) mRS shift analysis at 90 days after randomization (3) NIHSS improvement of 8 points or more at 48 hours after randomization (4) QOL (EQ-5D-3L) at 90 days after randomization (5) Symptomatic intracranial hemorrhage (ICH) within 48 hours after randomization (6) Any ICH within 48 hours after randomization (7) All cause death (mRS 6) within 90 days after randomization (8) Recurrence of cerebral infarction within 90 days after randomization (9) Decompressive craniectomy within 7 days after randomization

—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactKazutaka Uchida

Hyogo Medical University Department of Neurosurgery

fu-sakakibara@hyo-med.ac.jp0798-45-6455

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026