IAT-MeVO Trial Domain Within the ACT-GLOBAL Adaptive Platform Trial
NCT ID: NCT07336927
Last Updated: 2026-01-15
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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NOT_YET_RECRUITING
NA
614 participants
INTERVENTIONAL
2026-01-01
2030-12-31
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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Endovascular Treatment Group
Recieving intra-arterial thrombolysis-based EVT after randomization.
Endovascular Treatment
Patients will receive IAT-based EVT in addition to medical treatment. IAT with TNK will be performed first. If adequate dosing fails to achieve reperfusion, the surgical team may evaluate the need for aspiration or stent retriever thrombectomy. For second-order branches (M2/A1/P1 segments), the number of retrieval attempts must not exceed three; for third-order branches (M3/A2/P2 and beyond), no more than two attempts are allowed.
\*Arterial thrombolysis protocol: Dose: 0.125 mg/kg body weight, maximum 12.5 mg
\*No restrictions will be placed on the choice of aspiration catheters or stent retrievers used in this study.
Best Medical Management Group
Upon enrollment, patients will receive best medical management alone.
No interventions assigned to this group
Interventions
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Endovascular Treatment
Patients will receive IAT-based EVT in addition to medical treatment. IAT with TNK will be performed first. If adequate dosing fails to achieve reperfusion, the surgical team may evaluate the need for aspiration or stent retriever thrombectomy. For second-order branches (M2/A1/P1 segments), the number of retrieval attempts must not exceed three; for third-order branches (M3/A2/P2 and beyond), no more than two attempts are allowed.
\*Arterial thrombolysis protocol: Dose: 0.125 mg/kg body weight, maximum 12.5 mg
\*No restrictions will be placed on the choice of aspiration catheters or stent retrievers used in this study.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed as acute ischemic stroke;
3. Isolated medium distal vessel occlusion (i.e. an occlusion of the M2, the M3/M4 segment of the MCA, the A1/ A2/A3 segment of the ACA or the P1/P2/P3 segment of the PCA) confirmed by CT or MR Angiography;
4. Time from onset (or last-seen-well) to randomization \< 24h;
5. Has not received intravenous thrombolysis and is considered unsuitable for it based on the treating clinician's assessment.
6. NIHSS ≥ 5, or NIHSS ≤ 4 with disabling deficit (e.g. severe aphasia, hemianopia, hemiplegia/loss of function in one side) or fluctuating symptoms at the time of randomization;
7. For patients within 6 h of onset: No visually apparent hypodensity is observed on non-contrast CT compared with the contralateral white matter, or no hyperintensity is seen on fluid-attenuated inversion recovery (FLAIR) imaging; For patients presenting 6-24 h after onset: A perfusion imaging-based ischemic core mismatch ratio \>1.2 and an infarct core volume \<50 mL are required;
8. Pre-stroke mRS ≤ 1；
9. Patient/Legally Authorized Representative has signed the Informed Consent form.
Exclusion Criteria
2. Concurrent multiple (≥2) intracranial arterial occlusions;
3. Suspected cerebral vasculitis, septic embolism, or infective endocarditis as the cause of vessel occlusion;
4. Suspected arterial dissection;
5. Clinical assessment of conditions unsuitable for interventional therapy (e.g., severe contrast agent allergy or absolute contraindications to iodine contrast agent; severe renal insufficiency, glomerular filtration rate \< 30ml/min or serum creatinine \> 220μmol/L (2.5 mg/dl));
6. Unsuitable for arterial thrombolytic therapy (e.g., known history of hereditary or acquired hemorrhagic disease and/or platelet count \<50×109/L; abnormal coagulation function (INR\>1.7); oral anticoagulants were taken within 24 - 48 hours before onset within APTT \> 3 times normal; recent medical history or clinical manifestations of brain tumors other than meningiomas);
7. Any terminal disease with life expectancy \<1 year;
8. Pregnancy or lactation;
9. Concurrent participation in another investigational drug or device study that could interfere with the present trial;
10. Other circumstances that participation is not deemed appropriate.
18 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Mianyang Central Hospital
OTHER
Chengdu First People's Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
Deyang People's Hospital
OTHER
Suining Central Hospital
OTHER
The Second People's Hospital of Chengdu
OTHER
Bo Wu
OTHER
Responsible Party
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Bo Wu
Chief Physician/Clinical Professor
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025(No.2695)
Identifier Type: -
Identifier Source: org_study_id
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