NCT07347665 Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery
| NCT ID | NCT07347665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hyogo Medical University |
| Condition | Endovascular Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-12-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07347665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 84 Years, studying Endovascular Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07347665 currently recruiting?
Yes, NCT07347665 is actively recruiting participants. Contact the research team at fu-sakakibara@hyo-med.ac.jp for enrollment information.
Where is the NCT07347665 trial being conducted?
This trial is being conducted at Nishinomiya, Japan, Nishinomiya, Japan.
Who is sponsoring the NCT07347665 clinical trial?
NCT07347665 is sponsored by Hyogo Medical University. The trial plans to enroll 200 participants.