Efficacy and Safety of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core: A Prospective, Multicenter, Randomized Controlled Trial
Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain. This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS \<7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.
• Clinical presentation or imaging findings consistent with posterior-circulation ischemic stroke.
• Basilar artery occlusion confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥10 before randomization.
• Age 18-85 years, inclusive.
• Baseline noncontrast CT, CTA source images, or diffusion-weighted MRI (DWI) demonstrating at least one of the following:
‣ Posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS) of 0-5; or
⁃ Pons-Midbrain Index (PMI) \>4.
• Randomization within 24 hours of the estimated time of basilar artery occlusion.
‣ The estimated time of basilar artery occlusion is defined as the sudden onset of stroke symptoms consistent with acute basilar artery occlusion.
⁃ For patients with wake-up stroke or an unknown time of symptom onset, the last known well (LKW) time will be used as the reference time; randomization must occur within 24 hours of LKW.
• Written informed consent provided by the participant or their legally authorized representative.