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Recruiting NCT07347665

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

No phase Interventional Endovascular Therapy Acute Ischemic Stroke Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovascular therapy.
Who it may be relevant to
Registry conditions: Endovascular Therapy, Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion. Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan, Thailand, Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • 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]
  • modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis [Time frame: 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 [Time frame: 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) [Time frame: 90 days after randomization]
  • Symptomatic intracranial hemorrhage [Time frame: 48 hours after randomization]
  • Any intracranial hemorrhage [Time frame: 48 hours after randomization]
  • All cause death [Time frame: 90 days after randomization]
  • Recurrence of cerebral infarction [Time frame: 90 days after randomization]
  • Decompressive craniectomy [Time frame: 7 days after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Hyogo Medical University — Nishinomiya
Thailand · 1 center
  • Thammasat University Hospital — Khlong Luang
Vietnam · 1 center
  • S.I.S Can Tho International General Hospital — Can Tho

Identifiers

NCT: NCT07347665 · R000066936

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗