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Basilar Artery Occlusion Chinese Endovascular Trial: Protocol for a prospective randomized controlled study

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机构: [1]Capital Med Univ, Dept Neurol, Xuanwu Hosp, Beijing, Peoples R China [2]Capital Med Univ, Dept Neurosurg, Xuanwu Hosp, Beijing, Peoples R China [3]Capital Med Univ, Cerebrovasc Dis Res Inst, Xuanwu Hosp, Beijing, Peoples R China [4]Peking Univ, Clin Res Inst, Beijing, Peoples R China [5]Capital Med Univ, Dept Emergency, Xuanwu Hosp, Beijing, Peoples R China [6]Cooper Univ Hosp, Cooper Neurol Inst, Camden, NJ USA
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关键词: Acute stroke therapy ischemic stroke treatment clinical trial intervention protocol

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Rationale There are no randomized trials examining the best treatment for acute basilar artery occlusion in the 6-24-hour time window. Aims To assess the safety and efficacy of thrombectomy for stroke due to basilar artery occlusion in patients randomized within 6-24 h from symptom onset or time last seen well. Sample size For an estimated difference of 20% in proportions of the primary outcome between the two groups, 318 patients will be included for 5% significance and 90% power with a planned interim analysis after two-thirds of the sample size (212 patients) have achieved the 90 days follow-up. Methods and design A prospective, multi-center, randomized, controlled, open-label and blinded-endpoint trial. The randomization employs a 1:1 ratio of mechanical thrombectomy with the detachable Solitaire thrombectomy device and best medical therapy (BMT) vs. BMT alone. Study outcomes The primary outcome will be the proportion of patients achieving modified Rankin Scale (mRS) 0-3 at 90 days. Key secondary outcomes are: dramatic early favorable response, dichotomized mRS score (0-2 vs. 3-6 and 0-4 vs. 5-6) at 90 days, ordinal (shift) mRS analysis at 90 days, infarct volume at 24 h, vessel recanalization at 24 h in both treatment arms, and successful recanalization in the thrombectomy arm according to the modified thrombolysis in cerebral infarction (mTICI) classification defined as mTICI 2 b or 3. Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage rates at 24 h, and procedure-related complications. Discussion Results from this trial will indicate whether mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects with acute stroke caused by basilar artery occlusion presenting within 6-24 h from symptom onset.

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出版当年[2021]版:
大类 | 2 区 医学
小类 | 3 区 临床神经病学 3 区 外周血管病
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 临床神经病学 2 区 外周血管病
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出版当年[2020]版:
Q1 PERIPHERAL VASCULAR DISEASE Q1 CLINICAL NEUROLOGY
最新[2023]版:
Q1 CLINICAL NEUROLOGY Q1 PERIPHERAL VASCULAR DISEASE

影响因子: 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

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第一作者机构: [1]Capital Med Univ, Dept Neurol, Xuanwu Hosp, Beijing, Peoples R China
通讯机构: [*1]Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, Beijing, China.
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