{
  "abstract": "Background Endovascular treatment (EVT) is safe and effective in treating acute ischaemic stroke due to basilar artery occlusion (AIS-BAO); nonetheless, the impact of intravenous thrombolysis (IVT) on its efficacy remains unclear.Objective To compare the effectiveness and safety of EVT with or without prior IVT in treating AIS-BAO patients within 4.5 hours after stroke onset.Methods and design A multicentre, prospective, randomised, open-label controlled clinical trial with blinded assessment of endpoints. 340 patients will be consecutively randomised to receive IVT plus EVT or direct EVT in a ratio of 1:1 from about 100 hospitals in China. An interim analysis is planned when one-third (114) of the patients have completed the primary endpoint follow-ups. It anticipates that IVT plus EVT demonstrates superiority over direct EVT. If the superiority of IVT plus EVT over direct EVT is less than expected, the sample size may be expanded by up to 20% of the original size. If the efficacy of the two groups is similar, it will shift to a non-inferiority hypothesis, aiming to evaluate whether direct EVT is non-inferior to IVT plus EVT.Outcome The primary endpoint is the proportion of independent neurological function defined as a modified Rankin Scale score of 0 to 2 at 90±14 days after stroke onset.Discussion This trial is expected to provide novel evidence of the superiority or non-inferiority between EVT with or without IVT in the treatment of patients with AIS-BAO.Trial registration NCT05631847 at ClinicalTrials.gov and ChiCTR2300070584 at Chictr.org.cn.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Yang Xiang"
    },
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Shu Yang"
    },
    {
      "affiliations": [
        "Department of Neurology, Xindu District People’s Hospital of Chengdu, Chengdu, Sichuan, China"
      ],
      "name": "Lei Guo"
    },
    {
      "affiliations": [
        "Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, Beijing, China"
      ],
      "name": "Chongya Dong"
    },
    {
      "affiliations": [
        "Department of Radiology, Amsterdam University Medical Centres, Amsterdam, The Netherlands"
      ],
      "name": "Charles B L M Majoie"
    },
    {
      "affiliations": [
        "Department of Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA"
      ],
      "name": "Adnan H Siddiqui"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Icahn School of Medicine at Mount Sinai Hospital, Mount Sinai Health System, New York, NY, USA"
      ],
      "name": "J Mocco"
    },
    {
      "affiliations": [
        "Department of Radiology, Amsterdam University Medical Centres, Amsterdam, The Netherlands"
      ],
      "name": "Fabiano Cavalcante"
    },
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Bing-Hu Li"
    },
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Jian-Hong Wang"
    },
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Bin Huang"
    },
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Duo-Zi Wang"
    },
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Neng-Wei Yu"
    },
    {
      "affiliations": [
        "Department of Neurology, Saint Antonius Hospital, Nieuwegein, The Netherlands"
      ],
      "name": "Wouter J Schonewille"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA"
      ],
      "name": "Aquilla S Turk"
    },
    {
      "affiliations": [
        "Department of Neurology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China"
      ],
      "name": "Fu-Qiang Guo"
    }
  ],
  "title": "BEST-BAO: a multicentre, prospective, randomised controlled trial of endovascular treatment with or without intravenous thrombolysis in acute ischaemic stroke due to basilar artery occlusion – study protocol and rationale",
  "uid": "7810ef74-63ff-56ea-85c1-a1bd7104204d"
}