Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion, Endovascular Therapy
Conditions
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.
Interventions
PROCEDUREEndovascular therapy
Endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Sponsors
Hyogo Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2 | 90 days after randomization | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Any intracranial hemorrhage | 48 hours after randomization |
| All cause death | 90 days after randomization |
| Recurrence of cerebral infarction | 90 days after randomization |
| Decompressive craniectomy | 7 days after randomization |
Countries
Japan, Thailand, Vietnam
Contacts
CONTACTKazutaka Uchida, MD, PhD
Outcome results
None listed