EVT in Acute Basilar Artery Occlusion With Large Infarction Core

Trial of Endovascular Treatment in Acute Basilar Artery Occlusion Patients With a Large Infarct Core

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone in acute basilar artery occlusion (BAO) patients with large infarct cores.

This trial aims to evaluate whether best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone improves neurological outcomes in acute basilar artery occlusion (BAO) patients with large infarct cores. A centralized 1:1 simple randomization design assigns participants to receive either EVT or BMM based on randomization results.

Inclusion Criteria:

• 1. Age ≥18 years. 2. Symptoms and signs consistent with basilar artery ischemia. 3. Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA); if vertebral artery occlusion is present, it must completely obstruct blood flow to the basilar artery.

  4. POST-NIHSS score ≥10 at randomization. 5. Time from symptom onset to randomization ≤24 hours (symptom onset defined as last known well time).

  6. pc-ASPECTS of 3-5 on CT/MRI (for patients aged <80 years) or pc-ASPECTS of 3-7 (for patients aged ≥80 years).

  7. Willingness of the patient or legally authorized representative to comply with protocol requirements and data collection procedures, with documented informed consent.

Exclusion Criteria:

• 1. Pre-stroke modified Rankin Scale (mRS) score >2. 2. Factors in the target vessel that are expected to prevent completion of endovascular treatment.

  3. Concurrent anterior and posterior circulation strokes or multivessel occlusions.

  4. Significant mass effect with imaging or clinical signs of obstructive hydrocephalus or tonsillar herniation.

  5. Basilar artery occlusion confirmed as chronic by prior imaging or investigator judgment.

  6. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.

  7. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.

  8. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.

  9. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.

  10. Known allergy to iodine contrast agents or other treatment-related drugs. 11. Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).

  12. Uncontrollable blood glucose <2.8 mmol/L or >22.2 mmol/L. 13. Pregnancy or breastfeeding. 14. Life expectancy <6 months. 15. Participation in other clinical studies that may affect outcome assessment. 16. Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).