Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS): protocol of a prospective, multicentre, randomised, controlled trial

被引:7
|
作者
Sun, Xuan [1 ,2 ]
Yang, Ming [1 ,2 ]
Sun, Dapeng [1 ,2 ]
Peng, Guangge [3 ]
Deng, Yiming [1 ,2 ]
Zhao, Xingquan [2 ]
Liu, Liping [2 ]
Ma, Ning [1 ,2 ]
Gao, Feng [1 ,2 ]
Mo, Dapeng [1 ,2 ]
Yu, Wengui [4 ]
Wang, Yongjun [2 ]
Wang, Yilong [2 ,5 ,6 ,7 ,8 ,9 ]
Miao, Zhongrong [1 ,2 ]
机构
[1] Capital Med Univ, Beijing Tiantan Hosp, Dept Intervent Neuroradiol, Beijing, Peoples R China
[2] Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China
[3] Capital Med Univ, Beijing Luhe Hosp, Dept Neurol, Beijing, Peoples R China
[4] Univ Calif Irvine, Comprehens Stroke & Cerebrovasc Ctr, Dept Neurol, Irvine, CA USA
[5] Chinese Inst Brain Res, Beijing, Peoples R China
[6] Natl Ctr Neurol Dis, Beijing, Peoples R China
[7] Capital Med Univ, Adv Innovat Ctr Human Brain Protect, Beijing, Peoples R China
[8] China Natl Clin Res Ctr Neurol Dis, Beijing, Peoples R China
[9] Capital Med Univ, Beijing Lab Oral Hlth, Beijing, Peoples R China
基金
国家重点研发计划; 中国国家自然科学基金;
关键词
Angioplasty; Atherosclerosis; Angiography; AGGRESSIVE MEDICAL THERAPY; ISCHEMIC-STROKE; RISK; MANAGEMENT; STANDARDS; REGISTRY;
D O I
10.1136/svn-2022-002288
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background The superiority of balloon angioplasty plus aggressive medical management (AMM) to AMM alone for symptomatic intracranial artery stenosis (sICAS) on efficacy and safety profiles still lacks evidence from randomised controlled trials (RCTs).Aim To demonstrate the design of an RCT on balloon angioplasty plus AMM for sICAS.Design Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS) trial is a multicentre, prospective, randomised, open-label, blinded end-point trial to investigate whether balloon angioplasty plus AMM could improve clinical outcome compared with AMM alone in patients with sICAS. Patients eligible in BASIS were 35-80 years old, with a recent transient ischaemic attack within the past 90 days or ischaemic stroke between 14 days and 90 days prior to enrolment due to severe atherosclerotic stenosis (70%-99%) of a major intracranial artery. The eligible patients were randomly assigned to receive balloon angioplasty plus AMM or AMM alone at a 1:1 ratio. Both groups will receive identical AMM, including standard dual antiplatelet therapy for 90 days followed by long-term single antiplatelet therapy, intensive risk factor management and life-style modification. All participants will be followed up for 3 years.Study outcomes Stroke or death in the next 30 days after enrolment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischaemic stroke or revascularisation from the qualifying artery after 30 days but before 12 months of enrolment, is the primary outcome.Discussion BASIS trail is the first RCT to compare the efficacy and safety of balloon angioplasty plus AMM to AMM alone in sICAS patients, which may provide an alternative perspective for treating sICAS.
引用
收藏
页码:66 / 74
页数:9
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