CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms.

Autor:	Spelle L; NEURI The Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, France laurent@spelle.fr.; Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France., Costalat V; Interventional Neuroradiology, Gui de Chauliac University hospital, Montpellier, France., Caroff J; NEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.; Assistance Publique - Hôpitaux de Paris Université Paris Saclay, Le Kremlin-Bicetre, Île-de-France, France., Wodarg F; Department of Radiology and Neuroradiology, Universitatsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany., Fischer S; Neuroradiology, Ruhr-Universität Bochum Medizinische Fakultät, Bochum, Nordrhein-Westfalen, Germany., Herbreteau D; Inreventional Neuroradiology, Centre Hospitalier Universitaire de Tours, Tours, France., Möhlenbruch MA; Neuroradiology, UniversitätsKlinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany., Januel AC; Diagnostic and Therapeutic Neuroradiology, Hospital Pierre Paul Riquet, Toulouse, Occitanie, France., Papagiannaki C; Interventional Neuroradiology, CHU de Rouen, Rouen, Normandie, France., Klisch J; Neuroradiology, HELIOS Klinikum Erfurt, Erfurt, Thüringen, Germany., Numminen J; Interventional Neuroradiology, Helsinki University Central Hospital, Helsinki, Uusimaa, Finland., Rautio R; Department of Radiology, TYKS, Turku, Finland., Berlis A; Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Augsburg, Augsburg, Bayern, Germany., Mihalea C; NEURI The Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, France.; Assistance Publique - Hôpitaux de Paris Université Paris Saclay, Le Kremlin-Bicetre, France., Chalumeau V; NEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.; Assistance Publique - Hôpitaux de Paris Université Paris Saclay, Le Kremlin-Bicetre, Île-de-France, France., Downer J; Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, Edinburgh, UK.; Department of Clinical Neurosciences, University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK., Cortese J; Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.; UMR CNRS no 7252, XLIM, Limoges, Aquitaine, France., Ikka L; NEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.; Assistance Publique - Hôpitaux de Paris Université Paris Saclay, Le Kremlin-Bicetre, Île-de-France, France., Gallas S; NEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.; Assistance Publique - Hôpitaux de Paris Université Paris Saclay, Le Kremlin-Bicetre, Île-de-France, France., Bester M; Department of Diagnostic and Interventional Neuroradiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Hamburg, Germany., Liebig T; Neuroradiology, LMU, Munchen, Germany., Velasco S; Neuroradiology, CHU Poitiers, Poitiers, France., Grimaldi L; Clinical Research Unit Bicetre hospital, Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, Île-de-France, France., Byrne J; Department of Neuroradiology, John Radcliffe Hospital, Oxford, Oxfordshire, UK., Szikora I; Interventional Neuroradiology, National Institute of Clinical Neurosciences, Budapest, Budapest, Hungary., Pierot L; Department of Interventional Neuroradiology, CHU de Reims, Reims, Grand Est, France.; Champagne University Hospital Group, Reims, Grand Est, France., Cognard C; Diagnostic and Therapeutic Neuroradiology, Hôpital Pierre Paul Riquet, Toulouse, Occitanie, France.
Jazyk:	angličtina
Zdroj:	Journal of neurointerventional surgery [J Neurointerv Surg] 2023 Nov 01. Date of Electronic Publication: 2023 Nov 01.
DOI:	10.1136/jnis-2023-020866
Abstrakt:	Background: Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. Methods: The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months. Results: A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed. Conclusion: Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. Trial Registration Number: NCT03844334. Competing Interests: Competing interests: JC acts as associate editor for Journal of NeuroInterventional Surgery, Neuroradiology and Journal of Neuroradiology; MAM acts as associate editor for Neuroradiology. RR acts as associate editor for Journal of Neuroradiology. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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