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.
Prestroke modified Rankin Scale (mRS) score ≥3.
Pregnancy or breastfeeding.
Allergy to contrast agents or nickel-titanium alloy.
Current participation in another clinical trial.
Parallel
Endovascular Therapy
Procedure/SurgeryEndovascular therapy consists of mechanical thrombectomy using stent retriever, direct aspiration, or combined techniques with the goal of achieving rapid and effective reperfusion of the occluded basilar artery.
Best Medical Management
Other interventionBest medical management includes intravenous thrombolysis when eligible, antithrombotic therapy, standard stroke unit care, management of vascular risk factors, blood pressure control, and supportive care according to current clinical guidelines.
Favorable Functional Outcome at 90 Days
Proportion of participants with a modified Rankin Scale score of 0 to 3 at 90 days. The modified Rankin Scale ranges from 0 to 6, with 0 indicating no symptoms, 5 indicating severe disability, and 6 indicating death.
Excellent Functional Outcome at 90 Days
Proportion of participants with a modified Rankin Scale score of 0 to 2 at 90 days.
Successful Recanalization on CTA/MRA
Proportion of participants with successful vascular recanalization on follow-up CTA or MRA.
Ordinal Shift in Modified Rankin Scale Score
Distribution of modified Rankin Scale scores at 90 days analyzed across all ordinal categories.
Symptomatic Intracranial Hemorrhage
Occurrence of symptomatic intracranial hemorrhage after randomization according to the prespecified trial definition.
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The First Affiliated Hospital of University of Science and Technology of China
Lead sponsor
Dalian Municipal Central Hospital
Collaborator
Linyi People's Hospital
Collaborator
Fujian Zhangzhou hospital
Collaborator
Shanghai Minhang District Central Hospital
Collaborator
