• Christian A Taschner, René Chapot, Vincent Costalat, Paolo Machi, Patrick Courthéoux, Xavier Barreau, Jérôme Berge, Laurent Pierot, Kryzsztof Kadziolka, Betty Jean, Raphaël Blanc, Alessandra Biondi, Hervé Brunel, Sophie Gallas, Ansgar Berlis, Denis Herbreteau, Joachim Berkefeld, Horst Urbach, Samer El Shikh, Jens Fiehler, Hubert Desal, Erika Graf, and Alain Bonafé.
• Department of Neuroradiology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. christian.taschner@uniklinik-freiburg.de.
• Neuroradiology. 2016 Aug 1; 58 (8): 777-86.

IntroductionHybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial.MethodsWeb-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up.ResultsFive hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8).ConclusionSecond-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils.Trial Registrationhttp://www.germanctr.de , DRKS00003132.

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