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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
372
The 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.
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, Anhui, China
RECRUITINGFirst Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
RECRUITINGShift 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.
Time frame: 90 (±7) days after randomization
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.
Time frame: 90 (±7)days after randomization
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.
Time frame: 90 (±7) days after randomization
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.
Time frame: 24 hours after randomization
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.
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Time frame: Discharge or 7±1 days after randomization
Successful reperfusion (modified Thrombolysis in Cerebral Infarction [mTICI] score, 2b-3)
Reperfusion was assessed using the modified Thrombolysis in Cerebral Infarction (mTICI) scale, which ranges from grade 0 (no perfusion) to grade 3 (complete reperfusion), with higher grades indicating greater reperfusion and therefore a better angiographic outcome.
Time frame: At the end of the operation