{
  "abstract": "Background Large vessel occlusion (LVO) stroke is associated with a high risk of permanent disability. There are no reliable tools providing periprocedural information on clot characteristics, such as composition and length, that may impact first pass effect, which has been shown to improve functional outcomes. In the first study of a novel technology, we evaluated whether the Clotild Smart Guidewire System (Clotild), an impedance-based device, can provide in situ information on clot characteristics during a mechanical thrombectomy procedure.Methods This is the first-in-human, international, multicentric, single-arm trial involving LVO stroke patients. Of 45 enrolled subjects, 41 constituted the safety population; 39 was the per protocol population, of which 26 subjects with complete impedance data comprised the performance population. The latter was divided into development (11 subjects) and validation (15 subjects) populations for prediction model development and assessment. The safety endpoint assessed Clotild-related intracranial vessel perforation/dissection. Performance endpoints evaluated Clotild’s ability to perform classification of impedance measurements distinguishing substantial versus negligible local content in red blood cells (RBCs) and platelets, to detect the arterial wall and the distal end of the clot.Results The safety endpoint was met in all subjects. Performance analysis comparing the agreement between Clotild’s output and impedance experts’ readings showed an area under the receiver operating characteristic curve (AUC) of 0.97 (95% CI 0.93 to 0.99) for RBC, and 0.94 (95% CI 0.89 to 0.98) for platelet clot composition. Regarding detection, Clotild’s performance showed an AUC of 0.69 (95% CI 0.59 to 0.77) for the arterial wall, and 0.83 (95% CI 0.59 to 1.00) for the distal end of the clot.Conclusions Clotild was proven safe to acquire impedance data and to provide information on in situ clot characteristics in large vessel occlusions.",
  "authors": [
    {
      "affiliations": [
        "Liverpool Hospital, Liverpool, New South Wales, Australia",
        "Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia",
        "Interventional Neuroradiology, Prince of Wales Hospital, Randwick, New South Wales, Australia"
      ],
      "name": "Andrew Cheung"
    },
    {
      "affiliations": [
        "Gold Coast University Hospital, Southport, Queensland, Australia"
      ],
      "name": "Henry Rice"
    },
    {
      "affiliations": [
        "Gold Coast University Hospital, Southport, Queensland, Australia"
      ],
      "name": "Laetitia de Villiers"
    },
    {
      "affiliations": [
        "Liverpool Hospital, Liverpool, New South Wales, Australia",
        "Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia",
        "Interventional Neuroradiology, Prince of Wales Hospital, Randwick, New South Wales, Australia"
      ],
      "name": "Nathan W Manning"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Centre Hospitalier Universitaire de Limoges, Limoges, France"
      ],
      "name": "Suzana Saleme"
    },
    {
      "affiliations": [
        "Gold Coast University Hospital, Southport, Queensland, Australia"
      ],
      "name": "Vinicius Carraro do Nascimento"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Centre Hospitalier Universitaire de Limoges, Limoges, France"
      ],
      "name": "Géraud Forestier"
    },
    {
      "affiliations": [
        "Sensome SAS, Massy, France"
      ],
      "name": "Julie Lafaurie-Janvore"
    },
    {
      "affiliations": [
        "Sensome SAS, Massy, France"
      ],
      "name": "Joachim Rambeau"
    },
    {
      "affiliations": [
        "Sensome SAS, Massy, France"
      ],
      "name": "Franz Bozsak"
    },
    {
      "affiliations": [
        "Mayo Clinic Minnesota, Rochester, Minnesota, USA"
      ],
      "name": "Ramanathan Kadirvel"
    },
    {
      "affiliations": [
        "Physiology & CÚRAM- Research Ireland Centre for Medical Devices, University of Galway, Galway, Ireland"
      ],
      "name": "Karen Doyle"
    },
    {
      "affiliations": [
        "Mayo Clinic Minnesota, Rochester, Minnesota, USA"
      ],
      "name": "Waleed Brinjikji"
    },
    {
      "affiliations": [
        "Neurology, UCLA, Los Angeles, California, USA"
      ],
      "name": "David S Liebeskind"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Centre Hospitalier Universitaire de Limoges, Limoges, France"
      ],
      "name": "Aymeric Rouchaud"
    },
    {
      "affiliations": [
        "Liverpool Hospital, Liverpool, New South Wales, Australia",
        "Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia"
      ],
      "name": "Dennis Cordato"
    },
    {
      "affiliations": [],
      "name": "On behalf of CLOT OUT investigators"
    }
  ],
  "title": "In situ impedance analysis device for clot characterization in large vessel occlusion acute ischemic stroke, a first-in-human study",
  "uid": "7a291b26-5065-5f49-909f-a6afc46e7062"
}