A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.
Age ≥18 years.
Symptoms and signs consistent with basilar artery ischemia.
Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA); if vertebral artery occlusion is present, it should completely block blood flow along the basilar artery.
First-time onset meeting the criteria for mild ischemic stroke diagnosis: NIHSS score <6.
Symptom progression due to intracranial hemorrhage, brain edema, or other clear causes (including but not limited to infarct hemorrhagic transformation, new infarction in non-occluded vascular regions, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
mRS >2.
Factors in the target vessel that are expected to prevent completion of endovascular treatment.
Multiple vessel occlusions.
Parallel
Endovascular Treatment
Procedure/SurgeryNeurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
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.
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.
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 NIHSS score from baseline at 24 hours postoperatively.
The NIHSS (National Institutes of Health Stroke Scale) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The score helps in gauging the degree of impairment caused by a stroke.
EQ-5D-5L scale at 90 (±7) days after randomization.
The EQ-5D-5L scale is a standardized tool used to measure a person's health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels to indicate the severity of problems in those areas.
Incidence of symptomatic intracerebral haemorrhage (sICH) within 24 (±6) hours after randomization (Heidelberg bleeding classification).
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 24 (±6) hours of endovascular treatment. 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 haemorrhage within 24 (±6) hours after randomization (Heidelberg bleeding classification).
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 24 (±6) hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma.
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.
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