About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1. Pre-stroke modified Rankin Scale (mRS) score >2. 2. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
Trial design
Parallel
Treatments tested in this trial
Endovascular Treatment
Procedure/SurgeryThe vascular access route is selected based on the patient's anatomical characteristics and operator discretion. Endovascular treatment (EVT) procedures must adhere to each participating center's standardized operating protocols. Upon confirmation of vascular occlusion, EVT may be performed using devices approved by China's National Medical Products Administration (NMPA). Based on lesion-specific features and operator judgment, permissible techniques include stent retriever thrombectomy, aspiration thrombectomy, balloon angioplasty with or without stenting, or intra-arterial thrombolysis. Investigational devices are strictly prohibited.
Treatment groups
Trial outcomes
Primary outcomes
Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.
Shift analysis is a statistical method used to evaluate the overall distribution change in modified Rankin Scale (mRS) scores, assessing whether an intervention leads to a general shift toward better outcomes across all score categories.
Secondary outcomes
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization.
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Change in Posterior National Institutes of Health Stroke Scale (POST-NIHSS) from baseline at 24 hours after randomization
The Posterior National Institutes of Health Stroke Scale (POST-NIHSS) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The POST-NIHSS ranges from 0 to 52, with higher scores indicating more severe neurological deficits and a worse clinical condition.The score helps in gauging the degree of impairment caused by a stroke.
Change in Posterior National Institutes of Health Stroke Scale (POST-NIHSS) from baseline at discharge or 7±1 days after randomization.
The Posterior National Institutes of Health Stroke Scale (POST-NIHSS) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The POST-NIHSS ranges from 0 to 52, with higher scores indicating more severe neurological deficits and a worse clinical condition.The score helps in gauging the degree of impairment caused by a stroke.
Other outcomes
All-cause mortality at 90 (±7) days after randomization.
All-cause mortality refers to the rate of death from any cause within a specific time period, without considering the underlying cause of death.
Incidence of symptomatic intracerebral hemorrhage (sICH) within 48 hours after randomization (Heidelberg bleeding classification).
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours after randomization. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. The sICH was defined as ICH associated with a worsening of 4 or more points on the NIHSS or resulting in death and cerebral herniation, which were not present at baseline.
Incidence of any intracerebral hemorrhage within 48 hours after randomization (Heidelberg bleeding classification).
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours after randomization. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma.
Sponsors and contacts
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The First Affiliated Hospital of Hainan Medical University
Lead sponsor
Heyuan people's Hospital
Collaborator
Wuhan No.1 Hospital
Collaborator
People's Hospital of Lixin Country
Collaborator
The Eighth Affiliated Hospital of Southern Medical University
Collaborator
Longyan City First Hospital
Collaborator
People's Hospital of Guoyang County
Collaborator
Maoming Hospital of Traditional Chinese Medicine
Collaborator
The Central Hospital of Xiangtan
Collaborator
The Fourth Hospital of Liuan
Collaborator
Wuwei City People's Hospital
Collaborator
Dongguan People's Hospital
Collaborator
Jingmen Central Hospital
Collaborator
THE SECOND PEOPLE'S HOSPITAL, WUHU
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
The First Hospital of Putian City
Collaborator
Yijishan Hospital
Collaborator
Liaocheng People's Hospital
Collaborator
People's Hospital of Dongxihu District
Collaborator
First People's Hospital of Yulin
Collaborator
Wuhan Central Hospital
Collaborator
Tongliao People's Hospital
Collaborator
Huaibei Miner General Hospital, Huaibei, China.
Collaborator
The First People's Hospital of Zhangjiagang
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
The affiliated Changsha Hospital of Xiangya School of Medicine, Central South University
Collaborator
Wangjiang People's Hospital of Anhui Province
Collaborator
The Third Affiliated Hospital of Guangzhou Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Maanshan People's Hospital
Collaborator
People's Hospital of Yingshang County
Collaborator
Haiyan People's Hospital
Collaborator
The First Affiliated Hospital of the University of Science and Technology of China
Collaborator