Clinical evidence standards for high-risk endovascular devices in ischemic stroke: a European multisociety consensus
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.
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BibTeX
@article{taschner2026clinical,
title = {{Clinical evidence standards for high-risk endovascular devices in ischemic stroke: a European multisociety consensus}},
author = {Christian Taschner and Jens Fiehler and Valeria Caso and Markus Möhlenbruch and Anne-Christine Januel and Luca Valvassori and Mohamed Aggour and Jan-Hendrik Buhk and Franziska Dorn and Matthias Gawlitza and Adrien Guenego and Johannes Kaesmacher and Zsolt Kulcsar and Jawid Madjidyar and Adam Rennie and Aymeric Rouchaud and Tilman Schubert and Wim van Zwam and Ivan Vukasinovic and Kamil Zeleňák and Isil Saatci and Anna Bopp and Jose Daniel Revelo and Theo Demerath and Johanna Ospel},
journal = {Journal of Neurointerventional Surgery},
year = {2026},
month = jun,
doi = {10.1136/jnis-2026-025448},
url = {https://hal.science/hal-05751598v1},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Clinical evidence standards for high-risk endovascular devices in ischemic stroke: a European multisociety consensus
AU - Christian Taschner
AU - Jens Fiehler
AU - Valeria Caso
AU - Markus Möhlenbruch
AU - Anne-Christine Januel
AU - Luca Valvassori
AU - Mohamed Aggour
AU - Jan-Hendrik Buhk
AU - Franziska Dorn
AU - Matthias Gawlitza
AU - Adrien Guenego
AU - Johannes Kaesmacher
AU - Zsolt Kulcsar
AU - Jawid Madjidyar
AU - Adam Rennie
AU - Aymeric Rouchaud
AU - Tilman Schubert
AU - Wim van Zwam
AU - Ivan Vukasinovic
AU - Kamil Zeleňák
AU - Isil Saatci
AU - Anna Bopp
AU - Jose Daniel Revelo
AU - Theo Demerath
AU - Johanna Ospel
PY - 2026
DA - 2026/06/23
JO - Journal of Neurointerventional Surgery
DO - 10.1136/jnis-2026-025448
UR - https://hal.science/hal-05751598v1
AB - 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.
SN - 1759-8478
SN - 1759-8486
ER -