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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorHyogo Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endovascular therapy

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Medical therapy with endovascular therapyExperimental treatment 1 intervention
Group B: Medical therapy aloneNo intervention 0 interventions

Trial outcomes

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.

Time frame
90 days after randomization

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

Other outcomes

Sponsors and contacts

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