RT Journal Article
SR Electronic
T1 Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS): protocol of a prospective, multicentre, randomised, controlled trial
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 66
OP 74
DO 10.1136/svn-2022-002288
VO 9
IS 1
A1 Sun, Xuan
A1 Yang, Ming
A1 Sun, Dapeng
A1 Peng, Guangge
A1 Deng, Yiming
A1 Zhao, Xingquan
A1 Liu, Liping
A1 Ma, Ning
A1 Gao, Feng
A1 Mo, Dapeng
A1 Yu, Wengui
A1 Wang, Yongjun
A1 Wang, Yilong
A1 Miao, Zhongrong
YR 2024
UL http://svn.bmj.com/content/9/1/66.abstract
AB 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.Trial registration number NCT03703635; https://www.clinicaltrials.gov.All data are available to researchers on request for purposes of reproducing the results or replicating the procedure by directly contacting the corresponding author.