IAT-MeVO Trial Domain Within the ACT-GLOBAL Adaptive Platform Trial

Efficacy and Safety of Endovascular Therapy With Intra-Arterial Thrombolysis for Medium Vessel Occlusion Stroke--the IAT-MeVO Trial

IAT-MeVO is an international, multicenter, prospective, randomised, open-label, blinded end-point assessed (PROBE) trial, to evaluate the efficacy and safety of endovascular therapy (EVT) [intra-arterial thrombolysis (IAT)-based] versus best medical management (BMT) in patients with acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) who are ineligible for intravenous thrombolysis (IV) within 24 h of onset.

Inclusion Criteria:

1. Age ≥ 18 y;
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:

1. Any evidence of intracranial hemorrhage on qualifying imaging;
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.