Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery
NCT ID: NCT07347665
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-12-01
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Medical therapy with endovascular therapy
Endovascular therapy
Endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Medical therapy alone
No interventions assigned to this group
Interventions
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Endovascular therapy
Endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
84 Years
ALL
No
Sponsors
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Hyogo Medical University
OTHER
Responsible Party
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Kazutaka Uchida
Associate Professor (Stroke Center)
Locations
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Hyogo Medical University
Nishinomiya, Hyōgo, Japan
Hyogo Medical University
Nishinomiya, Hyōgo, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R000066936
Identifier Type: -
Identifier Source: org_study_id
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