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][1]; . All data are available to researchers on request for purposes of reproducing the results or replicating the procedure by directly contacting the corresponding author. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03703635&atom=%2Fsvnbmj%2F9%2F1%2F66.atom

中文翻译：

---

球囊血管成形术治疗症状性颅内动脉狭窄 (BASIS)：一项前瞻性、多中心、随机、对照试验方案

背景 球囊血管成形术联合积极医疗管理 (AMM) 相对于单独使用 AMM 治疗症状性颅内动脉狭窄 (sICAS) 在疗效和安全性方面的优越性仍缺乏随机对照试验 (RCT) 的证据。目的 展示针对 sICAS 的球囊血管成形术加 AMM 的随机对照试验 (RCT) 设计。设计球囊血管成形术治疗症状性颅内动脉狭窄 (BASIS) 试验是一项多中心、前瞻性、随机、开放标签、盲法终点试验，旨在研究球囊血管成形术联合 AMM 与单独使用 AMM 相比是否可以改善 sICAS 患者的临床结果。符合 BASIS 资格的患者年龄为 35-80 岁，在过去 90 天内近期发生过短暂性脑缺血发作，或在入组前 14 天至 90 天内因主要颅内动脉严重动脉粥样硬化狭窄 (70%–99%) 发生缺血性卒中动脉。符合条件的患者按 1:1 的比例随机分配接受球囊血管成形术加 AMM 或单独接受 AMM。两组将接受相同的 AMM，包括为期 90 天的标准双重抗血小板治疗，然后是长期单一抗血小板治疗、强化危险因素管理和生活方式改变。所有参与者都将被随访 3 年。研究结果 主要结局是入组后或随访期间对合格病变进行球囊血管成形术后的未来 30 天内发生中风或死亡，或者入组 30 天后但 12 个月之前合格动脉发生任何缺血性中风或血运重建。 。讨论 BASIS 试验是第一个比较球囊血管成形术联合 AMM 与单独 AMM 在 sICAS 患者中的疗效和安全性的随机对照试验，这可能为治疗 sICAS 提供另一种视角。试用注册号[NCT03703635][1]；。所有数据均可根据要求提供给研究人员，以便通过直接联系相应作者来重现结果或复制程序。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03703635&atom=%2Fsvnbmj%2F9%2F1%2F66.atom