title: GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results.
abstract: BACKGROUND
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  http://www.germanctr.de , DRKS00003132.
authors.affiliation: Department of Neuroradiology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. christian.taschner@uniklinik-freiburg.de.
authors.forename: Christian A
authors.initials: CA
authors.lastname: Taschner
authors.affiliation: Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany.
authors.forename: René
authors.initials: R
authors.lastname: Chapot
authors.affiliation: Department of Neuroradiology, CHU Montpellier, Montpellier, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Costalat
authors.affiliation: Department of Neuroradiology, CHU Montpellier, Montpellier, France.
authors.forename: Paolo
authors.initials: P
authors.lastname: Machi
authors.affiliation: Department of Neuroradiology, CHU Caen, Caen, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Courthéoux
authors.affiliation: Department of Neuroradiology, CHU Bordeaux, Bordeaux, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Barreau
authors.affiliation: Department of Neuroradiology, CHU Bordeaux, Bordeaux, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Berge
authors.affiliation: Department of Neuroradiology, CHU Reims, Reims, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Pierot
authors.affiliation: Department of Neuroradiology, CHU Reims, Reims, France.
authors.forename: Kryzsztof
authors.initials: K
authors.lastname: Kadziolka
authors.affiliation: Department of Neuroradiology, Hôpital Gabriel-Montpied, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: Betty
authors.initials: B
authors.lastname: Jean
authors.affiliation: Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France.
authors.forename: Raphaël
authors.initials: R
authors.lastname: Blanc
authors.affiliation: Department of Neuroradiology, CHU Besançon, Besançon, France.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Biondi
authors.affiliation: Department of Neuroradiology, Hôpital La Timone, CHU Marseille, Marseille, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Brunel
authors.affiliation: Department of Neuroradiology, Hôpital Henri-Mondor, AP-HP, Créteil, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Gallas
authors.affiliation: Department of Radiology and Neuroradiology, Augsburg Hospital, Augsburg, Germany.
authors.forename: Ansgar
authors.initials: A
authors.lastname: Berlis
authors.affiliation: Department of Neuroradiology, CHU Tours, Tours, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Herbreteau
authors.affiliation: Institute of Neuroradiology, University Hospital Frankfurt, Frankfurt/Main, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Berkefeld
authors.affiliation: Department of Neuroradiology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Urbach
authors.affiliation: Department of Neuroradiology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
authors.forename: Samer
authors.initials: S
authors.lastname: El Shikh
authors.affiliation: Department of Neuroradiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Fiehler
authors.affiliation: Department of Neuroradiology, Hôpital G et R Laënnec, CHU Nantes, Nantes, France.
authors.forename: Hubert
authors.initials: H
authors.lastname: Desal
authors.affiliation: Clinical Trials Unit, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
authors.forename: Erika
authors.initials: E
authors.lastname: Graf
authors.affiliation: Department of Neuroradiology, CHU Montpellier, Montpellier, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Bonafé
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001807:Blood Vessel Prosthesis; D002533:Cerebral Angiography / Q000379:methods; D057510:Endovascular Procedures / Q000295:instrumentation*; D019544:Equipment Failure Analysis; D005260:Female; D005602:France; D005858:Germany; D006801:Humans; D020100:Hydrogels / Q000737:chemistry*; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010984:Platinum / Q000737:chemistry*; D011474:Prosthesis Design; D016896:Treatment Outcome
chemical_list: D020100:Hydrogels; D010984:Platinum
keywords: Hydrogel coils; Intracranial aneurysm; Randomized controlled trial