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GREAT—a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results

  • Interventional Neuroradiology
  • Published:
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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 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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Acknowledgments

The study was funded by MicroVention Inc., the manufacturers of the HydroSoft/HydroFrame coils. MicroVention Inc. supplied the electronic case report form for data entry. We would also like to thank the following: Core Lab: Hubert Desal and Jens Fiehler. Trial Steering Committee: Christian Taschner (Lead Investigator), Alain Bonafé (Co-ordinator: French Centres), Martin Schumacher, Matthias Reinhard and Vera van Velthoven. Data Monitoring and Safety Committee: Daniel Rüfenacht (Chair), Werner Hacke and Meinhard Kieser (Statistician).

Author information

Authors and Affiliations

  1. Department of Neuroradiology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany

    Christian A. Taschner, Horst Urbach & Samer El Shikh

  2. Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany

    René Chapot

  3. Department of Neuroradiology, CHU Montpellier, Montpellier, France

    Vincent Costalat, Paolo Machi & Alain Bonafé

  4. Department of Neuroradiology, CHU Caen, Caen, France

    Patrick Courthéoux

  5. Department of Neuroradiology, CHU Bordeaux, Bordeaux, France

    Xavier Barreau & Jérôme Berge

  6. Department of Neuroradiology, CHU Reims, Reims, France

    Laurent Pierot & Kryzsztof Kadziolka

  7. Department of Neuroradiology, Hôpital Gabriel-Montpied, CHU Clermont-Ferrand, Clermont-Ferrand, France

    Betty Jean

  8. Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France

    Raphaël Blanc

  9. Department of Neuroradiology, CHU Besançon, Besançon, France

    Alessandra Biondi

  10. Department of Neuroradiology, Hôpital La Timone, CHU Marseille, Marseille, France

    Hervé Brunel

  11. Department of Neuroradiology, Hôpital Henri-Mondor, AP-HP, Créteil, France

    Sophie Gallas

  12. Department of Radiology and Neuroradiology, Augsburg Hospital, Augsburg, Germany

    Ansgar Berlis

  13. Department of Neuroradiology, CHU Tours, Tours, France

    Denis Herbreteau

  14. Institute of Neuroradiology, University Hospital Frankfurt, Frankfurt/Main, Germany

    Joachim Berkefeld

  15. Department of Neuroradiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany

    Jens Fiehler

  16. Department of Neuroradiology, Hôpital G et R Laënnec, CHU Nantes, Nantes, France

    Hubert Desal

  17. Clinical Trials Unit, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany

    Erika Graf

Authors
  1. Christian A. Taschner
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  2. René Chapot
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  3. Vincent Costalat
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  4. Paolo Machi
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  5. Patrick Courthéoux
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  6. Xavier Barreau
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  7. Jérôme Berge
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  8. Laurent Pierot
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  9. Kryzsztof Kadziolka
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  10. Betty Jean
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  11. Raphaël Blanc
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  12. Alessandra Biondi
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  13. Hervé Brunel
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  14. Sophie Gallas
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  15. Ansgar Berlis
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  16. Denis Herbreteau
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  17. Joachim Berkefeld
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  18. Horst Urbach
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  19. Samer El Shikh
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  20. Jens Fiehler
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  21. Hubert Desal
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  22. Erika Graf
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  23. Alain Bonafé
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Corresponding author

Correspondence to Christian A. Taschner.

Ethics declarations

We declare that all human studies have been approved by the leading ethics committee (Faculty of Medicine, Freiburg University, Freiburg, Germany [077/09]) and the local ethics committees and were authorized by the competent French and German authorities and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. We declare that all patients gave informed consent prior to inclusion in this study.

Conflict of interest

CAT has consulted for MicroVention Inc, Stryker Neurovascular, and Acandis GmbH.

Additional information

GREAT investigators

France

C Barbier. Department of Neuroradiology, CHU Caen, Caen

Jean Gabrillargues, Emanuel Chabert, A Fischer. Department of Neuroradiologie, Hôpital Gabriel-Montpied, CHU Clermont-Ferrand, Clermont-Ferrand

Frédéric Ricolfi. Department of Neuroradiology, CHU Dijon, Dijon

Charbel Mounayer. Department of Neuroradiology, CHU Limoges, Limoges

Marinette Moynier. Department of Neuroradiology, CHU Montpellier, Montpellier

Michel Piotin, Bruno Bartolini. Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris

Nader Sourour. Department of Neuroradiology, Hôpital Salpétrière, AP-HP, Paris

Jean-Yves Gauvrit. Department of Neuroradiology, CHU Rennes, Rennes

Eléonore Tollard. Department of Neuroradiology, CHU Rouen, Rouen

C Papgiannaki, Richard Bibi. Department of Neuroradiology, CHU Tours, Tours

Germany

Paul Stracke. Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen

Marc Schlamann, Sophia Göricke, Claudia Möller-Hartmann, Isabell Wanke. Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen

Richard du Mesnil de Rochemont. Institute of Neuroradiology, University Hospital Frankfurt, Frankfurt am Main

Stephan Meckel, Ulrike Bergmann. Department of Neuroradiology, Medical Centre-University of Freiburg, Freiburg

Elke Gizewski, Thorsten Schmidt. Department of Neuroradiology, University Hospital Giessen, Giessen

Christoph Groden. Department of Neuroradiology, Universitätsmedizin Mannheim, University of Heidelberg, Mannheim

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Taschner, C.A., Chapot, R., Costalat, V. et al. GREAT—a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results. Neuroradiology 58, 777–786 (2016). https://doi.org/10.1007/s00234-016-1693-y

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  • DOI: https://doi.org/10.1007/s00234-016-1693-y

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