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GREAT—a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment

  • Interventional Neuroradiology
  • Published:
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Abstract

The effectiveness of a hybrid hydrogel platinum detachable coil (HydroCoil; MicroVention Inc., Tustin, CA) for endovascular aneurysm treatment has been proven in a recently published RCT. Due to technical restrictions (coil stiffness, time restriction for placement), the HydroSoft coil as well as a corresponding 3D framing coil, the HydroFrame coil (MicroVention Inc., Tustin, CA), a class of new softer coils containing less hydrogel and swelling more slowly than the HydroCoil, have been developed and brought to clinical practice. The present study aims to compare the effectiveness of endovascular aneurysm treatment with coil embolization between patients allocated HydroSoft/HydroFrame versus bare platinum coiling. GREAT is a randomized, controlled, multicentre trial in patients bearing cerebral aneurysms to be treated by coil embolization. Eligible patients were randomized to either coil embolization with HydroSoft/HydroFrame coils (>50 % of administered coil length), or bare platinum coils. Inclusion criteria were as follows: age 18–75, ruptured aneurysm (WFNS 1–3) and unruptured aneurysm with a diameter between 4 and 12 mm. Anatomy such that endovascular coil occlusion deemed possible and willingness of the neurointerventionalist to use either HydroSoft/HydroFrame or bare platinum coils. Exclusion criteria were as follows: aneurysms previously treated by coiling or clipping. Primary endpoint is a composite of major aneurysm recurrence on follow-up angiography and poor clinical outcome (modified Rankin scale 3 or higher), both assessed at 18 months post treatment. Risk differences for poor outcomes will be estimated in a modified intention-to-treat analysis stratified by rupture status (DRKS-ID: DRKS00003132).

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References

  1. Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R (2002) International subarachnoid aneurysm trial (ISAT) collaborative group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet 360(9342):1267–1274

    Article  PubMed  Google Scholar 

  2. Taschner CA, Leclerc X, Gauvrit JY, Kerkeni A, El-Mahdy M, Lejeune JP, Pruvo JP (2007) Safety of endovascular treatment of intracranial aneurysms with a new, complex shaped Guglielmi detachable coil. Neuroradiology 49(9):761–766

    Article  PubMed  Google Scholar 

  3. White PM, Lewis SC, Gholkar A, Sellar RJ, Nahser H, Cognard C, Forrester L, Wardlaw JM, HELPS trial collaborators (2011) Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial. Lancet 377(9778):1655–1662

    Article  CAS  PubMed  Google Scholar 

  4. Tsumoto T, Niimi Y, Berenstein A (2009) Evaluation of the new HydroSoft coil in a canine model of bifurcation aneurysm. Laboratory investigation. J Neurosurg 111(1):11–16

    Article  PubMed  Google Scholar 

  5. Killer M, Kallmes D, Jones R, Ding Y, Vestal M, Hauser T, Virmani R, Cruise G (2010) Long-term angiographic and histological results of a new hydrogel-containing filling coil in experimental rabbit aneurysms. Minim Invasive Neurosurg 53(3):97–105

    Article  CAS  PubMed  Google Scholar 

  6. Guo XB, Fan YM, Zhang JN (2011) HydroSoft coil versus HydroCoil for endovascular aneurysm occlusion study: a single center experience. Eur J Radiol 79(2):e42–e46

    Article  PubMed  Google Scholar 

  7. Waldau B, Turk AS 3rd, Yashar P, Khaldi A, Turner RD 4th, Chaudry MI, Siddiqui AH, Levy EI, Hoh BL, Mocco J (2012) Perioperative safety of HydroSoft coils. J Neurointerv Surg 4(5):375–378

    Article  PubMed  Google Scholar 

  8. Park JH, Kang HS, Han MH, Jeon P, Yoo DS, Lee TH, Korean HydroSoft Registry Investigators (2011) Embolization of intracranial aneurysms with HydroSoft coils: results of the Korean multicenter study. AJNR Am J Neuroradiol 32(9):1756–1761

    Article  CAS  PubMed  Google Scholar 

  9. Lee JY, Seo JH, Lee SJ, Son YJ, Cho YD, Kang HS, Han MH (2014) Mid-term outcome of intracranial aneurysms treated with HydroSoft coils compared to historical controls treated with bare platinum coils: a single-center experience. Acta Neurochir (Wien) 156(9):1687–1694

    Article  Google Scholar 

  10. Roy D, Milot G, Raymond J (2001) Endovascular treatment of unruptured aneurysms. Stroke 32(9):1998–2004

    Article  CAS  PubMed  Google Scholar 

  11. Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D (2003) Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke 34(6):1398–1403

    Article  PubMed  Google Scholar 

  12. van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J (1988) Interobserver agreement for the assessment of handicap in stroke patients. Stroke 19:604–607

    Article  PubMed  Google Scholar 

  13. White PM, Raymond J (2009) Endovascular coiling of cerebral aneurysms using "bioactive" or coated-coil technologies: a systematic review of the literature. AJNR Am J Neuroradiol 30(2):219–226

    Article  CAS  PubMed  Google Scholar 

  14. Molyneux AJ, Clarke A, Sneade M, Mehta Z, Coley S, Roy D, Kallmes DF, Fox AJ (2012) Cerecyte coil trial: angiographic outcomes of a prospective randomized trial comparing endovascular coiling of cerebral aneurysms with either cerecyte or bare platinum coils. Stroke 43(10):2544–2550

    Article  CAS  PubMed  Google Scholar 

  15. McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Massó Romero J, Chaloupka JC, Bonafe A, Wakhloo AK, Tampieri D, Dowd CF, Fox AJ, Imm SJ, Carroll K, Turk AS, MAPS Investigators (2014) Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J Neuroradiol 35(5):935–942

    Article  PubMed  Google Scholar 

  16. Raymond J, Klink R, Chagnon M, Barnwell SL, Evans AJ, Mocco J, Hoh BL, Turk AS, Turner RD, Desal H, Fiorella D, Bracard S, Weill A, Guilbert F, Roy D (2014) PRET Collaborative Group Patients prone to recurrence after endovascular treatment: periprocedural results of the PRET randomized trial on large and recurrent aneurysms. AJNR Am J Neuroradiol 35(9):1667–1676

    Article  PubMed  Google Scholar 

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Acknowledgments

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

Ethical standards and patient consent

We declare that all human and animal studies have been approved by the leading Ethics Committee (Faculty of Medicine, Freiburg University, 077/09) and the local Ethics Committees and was authorized by the competent French and German authorities. The study is registered in the German Clinical Trials Register (DRKS-ID: DRKS00003132) and has 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 according to the requirements of the study protocol approved by the Ethics Committees in France and Germany.

Conflict of interest

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

Participating centres and investigators

France

Department of Neuroradiology, CHU Besançon, Besançon; Alessandra Biondi

Department of Neuroradiology, CHU Bordeaux, Bordeaux; Xavier Barreau, Jérôme Berge

Department of Neuroradiology, CHU Caen, Caen; Patrick Courthéoux, C Barbier

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

Department of Neuroradiology, CHU Dijon, Dijon; Frédéric Ricolfi

Department of Neuroradiology, CHU Limoges, Limoges, Charbel Mounayer

Department of Neuroradiology, Hôpital La Timone, CHU Marseille, Marseille; Hervé Brunel

Department of Neuroradiology, CHU Montpellier, Montpellier; Alain Bonafé, Vincent Costalat, Paolo Machi

Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris; Raphael Blanc, Michel Piotin, B Bartolini

Department of Neuroradiology, Hôpital Henri-Mondor, AP-HP, Paris; Sophie Gallas

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

Department of Neuroradiology, CHU Reims, Reims; Laurent Pierot, Kryzsztof Kadziolka

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

Department of Neuroradiology, CHU Rouen, Rouen; Eléonore Tollard

Department of Neuroradiology, CHU Tours, Tours; Denis Herbreteau, C Papgiannaki, Richard Bibi

Germany

Department of Diagnostic and Interventional Radiology and Neuroradiology, Augsburg Hospital, Augsburg; Ansgar Berlis

Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany; René Chapot, Paul Stracke

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

Institute of Neuroradiology, University Hospital Frankfurt, Frankfurt am Main; Joachim Berkefeld, Richard du Mesnil de Rochemont

Department of Neuroradiology, Medical Centre - University of Freiburg, Freiburg; Christian Taschner, Samer El Shikh, Stephan Meckel, Horst Urbach

Department of Neuroradiology, University Hospital Giessen, Giessen; Elke Gizewski

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

Author information

Authors and Affiliations

  1. Department of Neuroradiology, Medical Centre - University of Freiburg, Breisacherstrasse 64, 79106, Freiburg, Germany

    Christian 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 & Alain Bonafé

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

    Patrick Courthéoux

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

    Xavier Barreau & Jerome Berge

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

    Laurent Pierot & Kryzsztof Kadziolka

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

    Betty Jean

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

    Raphael 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 Diagnostic and Interventional 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, Universitätsmedizin Mannheim, University of Heidelberg, Mannheim, Germany

    Christoph Groden

  16. Clinical Trials Unit, Medical Centre - University of Freiburg, Freiburg, Germany

    Erika Graf

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

Correspondence to Christian Taschner.

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Taschner, C., Chapot, R., Costalat, V. et al. GREAT—a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment. Neuroradiology 57, 599–604 (2015). https://doi.org/10.1007/s00234-015-1501-0

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  • DOI: https://doi.org/10.1007/s00234-015-1501-0

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