{
  "abstract": "Background In this randomized controlled trial we aim to validate the efficacy and safety of a hydrogel vascular closure device (VCD) for hemostasis after transfemoral intervention.Methods Between January and August 2023, 212 patients were enrolled, including 202 in a non-inferiority randomized controlled trial (1:1 hydrogel vs ExoSeal; prespecified margin −10%) and 10 in a hydrogel-only observational arm (8 F). The primary endpoint was device success rate and secondary endpoints including hemostasis time and procedural blood loss.Results Among 102 hydrogel and 100 ExoSeal recipients, hydrogel had non-inferior success rates (99.02% vs 94.00%; 95% CI −0.27% to 11.74%). Hydrogel achieved significantly faster hemostasis (1.99 vs 3.14 min, P<0.001) and reduced blood loss (0.83 mL vs 8.93 mL, P<0.001). No major access site complications were observed in either group. No secondary complications occurred in patients in the experimental group and secondary complications occurred in one patient in the control group (P=0.497). The supplementary cohort of 10 patients supported the efficacy and safety of hydrogel VCD.Conclusions Hydrogel VCD shows non-inferior efficacy to ExoSeal for transfemoral cerebrovascular interventions, with superior hemostatic speed and reduced blood loss while maintaining comparable safety.Trial registration number ChiCTR2300068029 ( https://www.chictr.org.cn/showproj.html?proj=178962)",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China",
        "Department of Encephalopathy, Suzhou Integrated Traditional Chinese and Western Medicine Hospital, Suzhou, China"
      ],
      "name": "Shuhong Yu"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Zhichao Huang"
    },
    {
      "affiliations": [
        "Department of Neurology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, China"
      ],
      "name": "Zhimai Lyu"
    },
    {
      "affiliations": [
        "Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu, China"
      ],
      "name": "Min Li"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, Ganzhou People’s Hospital, Ganzhou, China"
      ],
      "name": "Bo Ye"
    },
    {
      "affiliations": [
        "Department of Neurology, Ganzhou People’s Hospital, Ganzhou, China"
      ],
      "name": "Guoyong Zeng"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Jiaping Xu"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Huaishun Wang"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Jie Hou"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Yuehui Liu"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Yage Zhao"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Zhiliang Guo"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China"
      ],
      "name": "Guodong Xiao"
    }
  ],
  "title": "A hydrogel vascular closure device for hemostasis after transfemoral intervention: a randomized controlled clinical trial",
  "uid": "d93b0f2f-a489-56e3-909d-934ead55352c"
}