{
  "abstract": "Background This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS).Methods This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0–2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure.Results Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0–2 at 90 days was 62.0% (95% CI 47.2–75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0–88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9–100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2–19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5–24.3%) for symptomatic cases and 32.0% (19.5–46.7%) for asymptomatic cases.Conclusion The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.",
  "authors": [
    {
      "affiliations": [
        "Neurology, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan"
      ],
      "name": "Nobuyuki Ohara"
    },
    {
      "affiliations": [
        "Neurosurgery, National Cerebral and Cardiovascular Center Hospital, Suita, Japan"
      ],
      "name": "Hirotoshi Imamura"
    },
    {
      "affiliations": [
        "Neurosurgery, Kindai University Hospital, Osakasayama, Japan"
      ],
      "name": "Tetsu Satow"
    },
    {
      "affiliations": [
        "Neurology, National Hospital Organization Osaka National Hospital, Osaka, Japan",
        "Division of Stroke Prevention and Treatment, University of Tsukuba, Tsukuba, Japan"
      ],
      "name": "Hiroshi Yamagami"
    },
    {
      "affiliations": [
        "Neurosurgery, Hyogo Medical University, Nishinomiya, Japan"
      ],
      "name": "Shinichi Yoshimura"
    },
    {
      "affiliations": [
        "Neurosurgery, Hiroshima University, Higashihiroshima, Japan",
        "Neurosurgery, Nagasaki University, Nagasaki, Japan"
      ],
      "name": "Nobutaka Horie"
    },
    {
      "affiliations": [
        "Neurosurgery, Juntendo University, Bunkyo-ku, Japan"
      ],
      "name": "Akira Ishii"
    },
    {
      "affiliations": [
        "Neurosurgery, National Hospital Organization Osaka National Hospital, Osaka, Japan"
      ],
      "name": "Toshiyuki Fujinaka"
    },
    {
      "affiliations": [
        "Division of Development and Discovery of Interventional Therapy, Tohoku University Hospital, Sendai, Japan"
      ],
      "name": "Yasushi Matsumoto"
    },
    {
      "affiliations": [
        "Neurosurgery, Showa University Fujigaoka Hospital, Yokohama, Japan"
      ],
      "name": "Tomoyuki Tsumoto"
    },
    {
      "affiliations": [
        "Endovascular Neurosurgery, Saitama Medical University International Medical Center, Hidaka, Japan"
      ],
      "name": "Shinya Kohyama"
    },
    {
      "affiliations": [
        "Neurosurgery, University of Tsukuba, Tsukuba, Japan"
      ],
      "name": "Yuji Matsumaru"
    },
    {
      "affiliations": [
        "Neurosurgery, National Cerebral and Cardiovascular Center Hospital, Suita, Japan"
      ],
      "name": "Koji Iihara"
    },
    {
      "affiliations": [
        "Neurosurgery, Graduate School of Medicine and Pharmaceutical Science for Education, Faculty of Medicine, University of Toyama, Toyama, Japan"
      ],
      "name": "Naoya Kuwayama"
    },
    {
      "affiliations": [
        "Stroke and Cerebrovascular Medicine, Kyorin University, Mitaka, Japan"
      ],
      "name": "Teruyuki Hirano"
    },
    {
      "affiliations": [
        "Neurosurgery, Shinrakuen Hospital, Niigata, Japan"
      ],
      "name": "Yasushi Ito"
    },
    {
      "affiliations": [
        "Data Science, National Cerebral and Cardiovascular Center, Suita, Japan"
      ],
      "name": "Haruko Yamamoto"
    },
    {
      "affiliations": [
        "Clinical Research Facilitation, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan"
      ],
      "name": "Yoji Nagai"
    },
    {
      "affiliations": [
        "Neurosurgery, Kyoto University, Kyoto, Japan"
      ],
      "name": "Chiaki Sakai"
    },
    {
      "affiliations": [
        "Neurovascular Research, Kobe City Medical Center General Hospital, Kobe, Japan",
        "Seijinkai Shimizu Hospital, Kyoto, Japan"
      ],
      "name": "Nobuyuki Sakai"
    },
    {
      "affiliations": [],
      "name": "VS-01 trial investigators"
    }
  ],
  "title": "Multicenter clinical trial evaluating the safety and efficacy of mechanical thrombectomy using the Versi Retriever",
  "uid": "1ebae886-8973-5391-a346-1595253433d4"
}