NCT07046299

Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct

Safety and Efficacy of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Core Infarct: A Prospective, Multicenter, Randomized, Open-Label Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.

Detailed description

This is a prospective, randomized, open-label, controlled trial evaluating endovascular therapy (EVT) for patients with acute basilar artery occlusion (BAO) and large core infarcts, defined by a pc-ASPECTS score of 3-5 on DWI or CT. Eligible participants aged 18-80 years and presenting within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either EVT plus standard medical therapy or medical therapy alone. Randomization will be stratified by age, baseline NIHSS, and onset-to-treatment time. The primary outcome is the proportion of patients achieving functional independence (mRS 0-3) at 90 days. Secondary outcomes include neurological improvement, mRS distribution, quality of life, and 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH). This study aims to generate high-quality evidence to guide treatment strategies for patients with acute basilar artery occlusion and large core infarcts.

Conditions

• Basilar Artery Occlusion
• Ischemic Stroke
• Large Core Infarct

Interventions

Type	Name	Description
PROCEDURE	Endovascular Therapy Plus Best Medical Treatment	Participants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, and stent implantation. The choice of treatment approach is left to the discretion of the treating physician, and combinations of techniques are allowed.
DRUG	Best Medical Treatment Alone	Participants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-02-29
• Completion: 2028-11-30
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: China