CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.

Autor:	Spelle L; NEURI The Brain Vascular Center, Interventional Neuroradiology, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, France laurent@spelle.fr.; Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France., Costalat V; Department of Interventional Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France., Caroff J; NEURI The Brain Vascular Center, Interventional Neuroradiology, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, France.; Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France., Wodarg F; Department of Neuroradiology, Universitätsklinikum Schleswig-Holstein, Kiel, Germany., Fischer S; Department of Neuroradiology, Universitätsklinikum Knappschaftskrankenhaus Bochum, Ruhr-Universität Bochum Medizinische Fakultät, Bochum, Germany., Herbreteau D; Department of Neuroradiology, CHU Tours, Tours, France., Möhlenbruch MA; Department of Neuroradiology, UniversitatsKlinikum Heidelberg, Heidelberg, Germany., Januel AC; Department of Diagnostic and Therapeutic Neuroradiology, Pierre Paul Riquet Hospital, Toulouse, France., Papagiannaki C; Department of Interventional Neuroradiology, CHU de Rouen, Rouen, France., Klisch J; Department of Neuroradiology, HELIOS Klinikum, Erfurt, Germany., Numminen J; Department of Neuroradiology, Helsinki University Central Hospital, Helsinki, Finland., Rautio R; Department of Radiology, Turku University Hospital, Turku, Finland., Berlis A; Department of Neuroradiology, University Hospital Augsburg, Augsburg, Germany., Mihalea C; NEURI The Brain Vascular Center, Interventional Neuroradiology, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, France., Chalumeau V; NEURI The Brain Vascular Center, Interventional Neuroradiology, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, 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; NEURI The Brain Vascular Center, Interventional Neuroradiology, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, France.; Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France., Ikka L; NEURI The Brain Vascular Center, Interventional Neuroradiology, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, France., Gallas S; NEURI The Brain Vascular Center, Interventional Neuroradiology, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, France., Bester M; Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Liebig T; Department of Neuroradiology, Ludwig-Maximilian University Hospital, Munchen, Germany., Velasco S; Department of Radiology, CHU Poitiers, Poitiers, France., Grimaldi L; Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France.; Clinical research unit, Bicetre Hospital, Assitance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, France., Byrne J; Department of Neuroradiology, John Radcliffe Hospital, Oxford, UK., Szikora I; Department of Neuroradiology, National Institute of Clinical Neurosciences, Budapest, Hungary., Pierot L; Department of Neuroradiology, Maison Blanche Hospital, Reims-Champagne-Ardenne University, Reims, France., Cognard C; Department of Diagnostic and Therapeutic Neuroradiology, Pierre Paul Riquet Hospital, Toulouse, France.
Jazyk:	angličtina
Zdroj:	Journal of neurointerventional surgery [J Neurointerv Surg] 2024 Jul 11. Date of Electronic Publication: 2024 Jul 11.
DOI:	10.1136/jnis-2024-021918
Abstrakt:	Background: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year. Objective: To evaluate angiographic stability at 1 year. Methods: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design. Results: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB. Competing Interests: Competing interests: JCa 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)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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