{
  "abstract": "Clinical evidence requirements for high-risk endovascular stroke devices in Europe remain heterogeneous, reflecting limited indication-specific methodological guidance under the European Medical Device Regulation (MDR) and resulting in uncertainty regarding the design and appraisal of clinical investigations across jurisdictions. We combined a systematic review of clinical studies evaluating endovascular stroke devices with a European multisociety expert consensus using a modified Delphi process. Eighteen experts representing the European Society of Minimally Invasive Neurological Therapy (ESMINT), the European Stroke Organisation (ESO), and the European Society of Neuroradiology (ESNR) participated in three Delphi rounds to formulate clinically grounded methodological recommendations for regulatory device evaluation. Prospective observational studies, including externally controlled comparative designs and single-arm studies based on performance benchmarks or precision-based estimation, were considered appropriate for most regulatory and clinical scenarios. For conceptually novel devices, no consensus was reached on a single optimal study design, leaving room for both randomized trials and observational approaches depending on the level of uncertainty. Consensus was achieved on key elements of study design, including multicenter structure, center and operator requirements, independent monitoring, imaging core-laboratory adjudication, endpoint selection, and data transparency. Functional independence at 90 days, successful reperfusion, and symptomatic intracranial hemorrhage were identified as core outcome domains. This clinician-driven consensus provides practical, indication-specific methodological recommendations for the design and conduct of regulatory studies evaluating single-use endovascular stroke devices. It complements existing frameworks, including CORE-MD and ISO-based guidance, by translating general principles into clinically applicable standards for neurointerventional research and regulatory trial design.",
  "authors": [
    {
      "affiliations": [
        "Department of Neuroradiology, Medical Centre–University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany"
      ],
      "name": "Christian A Taschner"
    },
    {
      "affiliations": [
        "Department of Diagnostic and Interventional Neuroradiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany"
      ],
      "name": "Jens Fiehler"
    },
    {
      "affiliations": [
        "Division of Neurology and Stroke Unit, Hospital of Saronno, ASST della Valle Olona, Busto Arsizio, Italy"
      ],
      "name": "Valeria Caso"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, Heidelberg University Medical Faculty Heidelberg, Heidelberg, BW, Germany"
      ],
      "name": "Markus A Möhlenbruch"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, CHU Toulouse, Toulouse, Occitanie, France"
      ],
      "name": "Anne-Christine Januel"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, ASST Santi Paolo e Carlo, Milan, Lombardy, Italy"
      ],
      "name": "Luca Valvassori"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, Clinique CHC MontLégia, Liège, Belgium"
      ],
      "name": "Mohamed Aggour"
    },
    {
      "affiliations": [
        "Department of Diagnostic and Interventional Neuroradiology, Asklepios Klinik St. Georg, Hamburg, Hamburg, Germany"
      ],
      "name": "Jan-Hendrik Buhk"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, University Hospital Bonn, Bonn, Germany"
      ],
      "name": "Franziska Dorn"
    },
    {
      "affiliations": [
        "Section of Neuroradiology, Jena University Hospital, Jena, Germany"
      ],
      "name": "Matthias Gawlitza"
    },
    {
      "affiliations": [
        "Department of Diagnostic and Interventional Neuroradiology, Erasme University Hospital, Brussels, Belgium"
      ],
      "name": "Adrien Guenego"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, Inselspital University Hospital Bern, Bern, Switzerland"
      ],
      "name": "Johannes Kaesmacher"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, University Hospital Zurich, Zurich, Switzerland"
      ],
      "name": "Zsolt Kulcsar"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, University Hospital Zurich, Zurich, Switzerland"
      ],
      "name": "Jawid Madjidyar"
    },
    {
      "affiliations": [
        "Department of Interventional Radiology, Great Ormond Street Hospital, London, England, UK"
      ],
      "name": "Adam Rennie"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, University Hospital Limoges, Limoges, France"
      ],
      "name": "Aymeric Rouchaud"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, University Hospital Zurich, Zurich, Switzerland"
      ],
      "name": "Tilman Schubert"
    },
    {
      "affiliations": [
        "Department of Radiology, Maastricht University Medical Centre+, Maastricht, LI, Netherlands"
      ],
      "name": "Wim H van Zwam"
    },
    {
      "affiliations": [
        "Department of Diagnostic and Therapeutic Neuroradiology, University Clinical Center of Serbia, Belgrade, Serbia"
      ],
      "name": "Ivan Vukasinovic"
    },
    {
      "affiliations": [
        "Department of Radiology, University Hospital Martin, Jessenius Faculty of Medicine, Comenius University, Martin, Slovakia"
      ],
      "name": "Kamil Zeleňák"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Liv Hospital Ankara, Ankara, Ankara, Turkey"
      ],
      "name": "Isil Saatci"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, Medical Centre–University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany"
      ],
      "name": "Anna Bopp"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, Medical Centre–University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany"
      ],
      "name": "Jose Daniel Revelo"
    },
    {
      "affiliations": [
        "Department of Neuroradiology, Medical Centre–University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany"
      ],
      "name": "Theo Demerath"
    },
    {
      "affiliations": [
        "Department of Radiology and Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada"
      ],
      "name": "Johanna M Ospel"
    }
  ],
  "title": "Clinical evidence standards for high-risk endovascular devices in ischemic stroke: a European multisociety consensus",
  "uid": "bdaaa4ba-c227-5280-a881-b0cc3db6c6e7"
}