Christian A Taschner1, René Chapot2, Vincent Costalat3, Paolo Machi3, Patrick Courthéoux4, Xavier Barreau5, Jérôme Berge5, Laurent Pierot6, Kryzsztof Kadziolka6, Betty Jean7, Raphaël Blanc8, Alessandra Biondi9, Hervé Brunel10, Sophie Gallas11, Ansgar Berlis12, Denis Herbreteau13, Joachim Berkefeld14, Horst Urbach15, Samer El Shikh15, Jens Fiehler16, Hubert Desal17, Erika Graf18, Alain Bonafé3. 1. Department of Neuroradiology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. christian.taschner@uniklinik-freiburg.de. 2. Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany. 3. Department of Neuroradiology, CHU Montpellier, Montpellier, France. 4. Department of Neuroradiology, CHU Caen, Caen, France. 5. Department of Neuroradiology, CHU Bordeaux, Bordeaux, France. 6. Department of Neuroradiology, CHU Reims, Reims, France. 7. Department of Neuroradiology, Hôpital Gabriel-Montpied, CHU Clermont-Ferrand, Clermont-Ferrand, France. 8. Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France. 9. Department of Neuroradiology, CHU Besançon, Besançon, France. 10. Department of Neuroradiology, Hôpital La Timone, CHU Marseille, Marseille, France. 11. Department of Neuroradiology, Hôpital Henri-Mondor, AP-HP, Créteil, France. 12. Department of Radiology and Neuroradiology, Augsburg Hospital, Augsburg, Germany. 13. Department of Neuroradiology, CHU Tours, Tours, France. 14. Institute of Neuroradiology, University Hospital Frankfurt, Frankfurt/Main, Germany. 15. Department of Neuroradiology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. 16. Department of Neuroradiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 17. Department of Neuroradiology, Hôpital G et R Laënnec, CHU Nantes, Nantes, France. 18. Clinical Trials Unit, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Abstract
INTRODUCTION:Hybrid 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. METHODS: Web-based randomization occurred in 15 medical centers in France and seven in Germany betweencoil 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. RESULTS:Five 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). CONCLUSION: Second-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 REGISTRATION: http://www.germanctr.de , DRKS00003132.
RCT Entities:
INTRODUCTION: Hybrid 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. METHODS: Web-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. RESULTS: Five 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). CONCLUSION: Second-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 REGISTRATION: http://www.germanctr.de , DRKS00003132.
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