• Christian A Taschner, René Chapot, Vincent Costalat, Paolo Machi, Patrick Courthéoux, Xavier Barreau, Jérôme Berge, Laurent Pierot, Krzysztof Kadziolka, Betty Jean, Raphaël Blanc, Alessandra Biondi, Hervé Brunel, Sophie Gallas, Ansgar Berlis, Denis Herbreteau, Joachim Berkefeld, Horst Urbach, Samer Elsheikh, Jens Fiehler, Hubert Desal, Erika Graf, and Alain Bonafé.
• From the Department of Neuroradiology (C.A.T., H.U., S.E.) and Clinical Trials Unit (E.G.), Faculty of Medicine, Medical Center-University of Freiburg, University of Freiburg, Germany; Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus, Essen, Germany (R.C.); Department of Neuroradiology, Centre Hospitalier Universitaire Montpellier, France (V.C., P.M., A.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Caen, France (P.C.); Department of Neuroradiology, Centre Hospitalier Universitaire Bordeaux, France (X.B., J.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Reims, France (L.P., K.K.); Department of Neuroradiology, Centre Hospitalier Universitaire Clermont-Ferrand, France (B.J.); Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France (R.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Besançon, France (A.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Marseille, France (H.B.); Department of Neuroradiology, Hôpital Henri-Mondor, Créteil, France (S.G.); Department of Neuroradiology, Augsburg Hospital, Germany (A.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Tours, France (D.H.); Institute of Neuroradiology, University Hospital Frankfurt, Germany (J.B.); Department of Neuroradiology, University Hospital Hamburg-Eppendorf, Germany (J.F.); and Department of Neuroradiology, Centre Hospitalier Universitaire Nantes, France (H.D.). christian.taschner@uniklinik-freiburg.de.
• Stroke. 2018 Mar 1; 49 (3): 667-674.

Background And PurposeEndovascular embolization of intracranial aneurysms with hydrogel-coated coils lowers the risk of major recurrence, but technical limitations (coil stiffness and time restriction for placement) have prevented their wider clinical use. We aimed to assess the efficacy of softer, second-generation hydrogel coils.MethodsA randomized controlled trial was conducted at 22 centers in France and Germany. Patients aged 18 to 75 years with untreated ruptured or unruptured intracranial aneurysms measuring 4 to 12 mm in diameter were eligible and randomized (1:1 using a web-based system, stratified by rupture status) to coiling with either second-generation hydrogel coils or bare platinum coils. Assist devices were allowed as clinically required. Independent imaging core laboratory was masked to allocation. Primary end point was a composite outcome measure including major aneurysm recurrence, aneurysm retreatment, morbidity that prevented angiographic controls, and any death during treatment and follow-up. Data were analyzed as randomized.ResultsRandomization began on October 15, 2009, and stopped on January 31, 2014, after 513 patients (hydrogel, n=256; bare platinum, n=257); 20 patients were excluded for missing informed consent and 9 for treatment-related criteria. Four hundred eighty-four patients (hydrogel, n=243; bare platinum, n=241) were included in the analysis; 208 (43%) were treated for ruptured aneurysms. Final end point data were available for 456 patients. Forty-five out of 226 (19.9%) patients in the hydrogel group and 66/230 (28.7%) in the control group had an unfavorable composite primary outcome, giving a statistically significant reduction in the proportion of an unfavorable composite primary outcome with hydrogel coils-adjusted for rupture status-of 8.4% (95% confidence interval, 0.5-16.2; P=0.036). Adverse and serious adverse events were evenly distributed between groups.ConclusionsOur results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms.Clinical Trial RegistrationURL: https://www.drks.de/drks_web/. Unique identifier: DRKS00003132.© 2018 The Authors.

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