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.
Initially mild ischemic stroke, defined as an initial NIHSS score <6, with no prior endovascular treatment for the index ischemic event.
Basilar artery occlusion, or vertebral artery occlusion resulting in complete interruption of antegrade flow into the basilar artery, documented by CTA, MRA, or DSA during the initially mild phase and before qualifying neurological deterioration.
Qualifying neurological deterioration occurring between 24 hours and 7 days after initial symptom onset, or after the last known well if symptom onset is unknown.
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, obstructive hydrocephalus, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
prestroke mRS >2.
Factors in the target vessel that are expected to prevent completion of endovascular treatment.
Concurrent anterior and posterior circulation strokes.
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 pre-randomization baseline at 24 hours after randomization.
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 48 hours after randomization (Heidelberg bleeding classification).
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 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 48 hours after randomization (Heidelberg bleeding classification).
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 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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First Affiliated Hospital of Wannan Medical College
Lead sponsor
The First Affiliated Hospital of the University of Science and Technology of China
Collaborator
First People's Hospital of Yulin
Collaborator
THE SECOND PEOPLE'S HOSPITAL, WUHU
Collaborator
People's Hospital of Guoyang County
Collaborator
Heyuan people's Hospital
Collaborator
The First Affiliated Hospital of Hainan Medical University
Collaborator
Wuwei City People's Hospital
Collaborator
People's Hospital of Lixin Country
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
Xihua People's Hospital
Collaborator
Wuhan No.1 Hospital
Collaborator
The Fourth Hospital of Liuan
Collaborator
Huaibei Miner General Hospital, Huaibei, China.
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
The First Affiliated Hospital of University of South China
Collaborator
Maoming Hospital of Traditional Chinese Medicine
Collaborator
People's Hospital of Linquan County
Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Haiyan People's Hospital
Collaborator
Haiyan County People's Hospital
Collaborator
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Collaborator
Yingshang County People's Hospital
Collaborator
The second affiliated hospital of Xuzhou medical university
Collaborator
The Central Hospital of Wuhan, Wuhan, Hubei, China
Collaborator
Suixi County Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Jinling Hospital, Medical School of Nanjing University
Collaborator
Xiangtan Central Hospital, Xiangtan, Hunan, China
Collaborator
Feidong County Hospital of Traditional Chinese Medicine, Hefei, Anhui, China
Collaborator
Dongguan People's Hospital, Dongguan, Guangdong, China
Collaborator
