Skip to main content
SpringerLink
Log in

EVIDENCE Trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms

  • Interventional Neuroradiology
  • Published:
Neuroradiology Aims and scope Submit manuscript

Abstract

Introduction

Endovascular treatment of large, wide-necked intracranial aneurysms with coils is associated with low rates of initial angiographic occlusion and high rates of recurrence. The Pipeline™ Embolization Device has shown high rates of complete occlusion in uncontrolled clinical series.

Methods

The study is a prospective, controlled, randomized, multicenter, phase 2 open-label trial. Intention-to-treat population includes age ≥18, unruptured saccular aneurysm located in the intra-dural area, neck diameter ≥4 and ≤10 mm, sac diameter ≥7 mm and ≤20 mm, “dome/neck” ratio is ≥1, diameter of the parent artery ≥2 mm and ≤5 mm, and no prior treatment of the aneurysm. Site can only participate if five patients have been previously treated with the Pipeline device. The primary end point of the study is complete occlusion of the aneurysm on angiogram performed 12 months after the endovascular procedure. Complete aneurysm occlusion is defined as the absence of visible blood flow, grade 1 according to the Raymond scale for the standard procedure group and grade 4 according to the grading scale of Kamran for the flow diverter group.

Results

The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up.

Conclusion

This paper details the trial design of the French EVIDENCE phase 2 trial, a blinded, controlled randomized trial of wide-neck intra-dural aneurysms amenable to either traditional endovascular strategy or flow diversion with Pipeline device.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Brown RD Jr, Broderick JP (2014) Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol 13:393–404

    Article  PubMed  Google Scholar 

  2. Wermer MJ, van der Schaaf IC, Algra A, Rinkel GJ (2007) Risk of rupture of unruptured intracranial aneurysms in relation to patient and aneurysm characteristics: an updated meta-analysis. Stroke 38:1404–1410

    Article  PubMed  Google Scholar 

  3. Haute Autorité de Santé [Senior Health Authority]. Actualisation du rapport d'évaluation sur les anévrismes sacculaires intracrâniens rompus: occlusion par voie endovasculaire versus exclusion par microchirurgie. [Update of the assessment report on ruptured saccular intracranial aneurysms: occlusion by endovascular route versus microsurgical clipping.] November 2009. http://www.has-sante.fr/portail/upload/docs/application/pdf/2009-12/rapport_anevrismes_intracraniens_rompus_2009-12-23_18-16-23_801.pdf, consulted on 4 January 2010

  4. Rinkel GJ, Djibuti M, Algra A, van Gijn J (1998) Prevalence and risk of rupture of intracranial aneurysms: a systematic review. Stroke 29:251–256

    Article  CAS  PubMed  Google Scholar 

  5. Gory B, Turjman F (2014) Endovascular treatment of 404 intracranial aneurysms treated with nexus detachable coils: short-term and mid-term results from a prospective, consecutive, European multicenter study. Acta Neurochir 156:831–837

    Article  PubMed  Google Scholar 

  6. Gory B, Kessler I, Seizem Nekiri G, Riva R, Al-Khawaldeh M, Mounayer C (2012) Initial experience of intracranial aneurysm embolization using the balloon remodeling technique with Scepter C, a new double-lumen balloon. Interv Neuroradiol 18:284–287

    CAS  PubMed Central  PubMed  Google Scholar 

  7. Pierot L, Cognard C, Spelle L, Moret J (2012) Safety and efficacy of balloon remodeling technique during endovascular treatment of intracranial aneurysms: critical review of the literature. AJNR Am J Neuroradiol 33:12–15

    Article  CAS  PubMed  Google Scholar 

  8. Gory B, Rouchaud A, Saleme S, Dalmay F, Riva R, Caire F, Mounayer C (2014) Endovascular treatment of middle cerebral artery aneurysms for 120 nonselected patients: a prospective cohort study. AJNR Am J Neuroradiol 35:715–720

    Article  CAS  PubMed  Google Scholar 

  9. Turjman F, Acevedo G, Moll T, Duquesnel J, Eloy R, Sindou M (1993) Treatment of experimental carotid aneurysms by endoprosthesis implantation: preliminary report. Neurol Res 15:181–184

    CAS  PubMed  Google Scholar 

  10. Shapiro M, Becske T, Sahlein D, Babb J, Nelson PK (2012) Stent-supported aneurysm coiling: a literature survey of treatment and follow-up. AJNR Am J Neuroradiol 33:159–163

    Article  CAS  PubMed  Google Scholar 

  11. Gory B, Klisch J, Bonafé A, Mounayer C, Beaujeux R, Moret J et al (2013) Solitaire AB stent-assisted coiling of wide-necked intracranial aneurysms: short-term results from a prospective, consecutive, European multicentric study. Neuroradiology 55:1373–1378

    Article  PubMed  Google Scholar 

  12. Gory B, Klisch J, Bonafé A, Mounayer C, Beaujeux R, Moret J et al (2014) Solitaire AB stent-assisted coiling of wide-necked intracranial aneurysms: mid-term results from the SOLARE study. Neurosurgery 75:215–219

    Article  PubMed  Google Scholar 

  13. Ferns SP, Sprengers ME, van Rooij WJ, Rinkel GJ, van Rijn JC, Bipat S, Sluzewski M et al (2009) Coiling of intracranial aneurysms: a systematic review on initial occlusion and reopening and retreatment rates. Stroke 40:523–529

    Article  Google Scholar 

  14. Gory B, Sigovan M, Vallecilla C, Courbebaisse G, Turjman F (2014) High-resolution MRI visualization of aneurysmal thrombosis after flow diverter stent placement. J Neuroimaging Mar 19

  15. Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF (2013) Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke 44:442–447

    Article  PubMed  Google Scholar 

  16. Gory B, Bonafé A, Pierot L, Spelle L, Berge J, Piotin M et al (2014) Safety and efficacy of flow-diverter stents in endovascular treatment of intracranial aneurysm: interest of the prospective DIVERSION observational study. J Neuroradiol 41:93–96

    Article  CAS  PubMed  Google Scholar 

  17. Chalouhi N, Tjoumakaris S, Starke RM, Gonzalez LF, Randazzo C, Hasan D et al (2013) Comparison of flow diversion and coiling in large unruptured intracranial saccular aneurysms. Stroke 44:2150–2154

    Article  PubMed  Google Scholar 

  18. Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G et al (2013) Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology 267:858–868

    Article  PubMed  Google Scholar 

  19. Armoiry X, Paysant M, Hartmann D, Aulagner G, Turjman F (2012) Interest of flow diversion prostheses in the management of unruptured intracranial aneurysms. J Vasc Med, Int

    Google Scholar 

  20. Hoh BL, Chi YY, Dermott MA, Lipori PJ, Lewis SB (2009) The effect of coiling versus clipping of ruptured and unruptured cerebral aneurysms on length of stay, hospital cost, hospital reimbursement, and surgeon reimbursement at the university of Florida. Neurosurgery 64:614–621

    Article  PubMed  Google Scholar 

  21. Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A et al (2003) Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke 34:1398–1403

    Article  PubMed  Google Scholar 

  22. Kamran M, Yarnold J, Grunwald IQ, Byrne JV (2011) Assessment of angiographic outcomes after flow diversion treatment of intracranial aneurysms: a new grading scheme. Neuroradiology 53:501–508

    Article  PubMed  Google Scholar 

Download references

Ethical standards and patient consent

We declare that all human and animal studies have been approved by the Comité de Protection des Personnes SUD-EST IV (12/060) 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

FT consults for Balt, Covidien and Codman. AB consults for Covidien, Stryker Neurovascular and Codman.

Author information

Authors and Affiliations

  1. Department of Interventional Neuroradiology, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, 59 Bd Pinel, 69677, Bron, France

    Francis Turjman, Roberto Riva & Benjamin Gory

  2. Department of Radiology, Clairval Private Hospital, Marseille, France

    Olivier Levrier & Xavier Combaz

  3. Department of Neuroradiology, Montpellier University Hospital, Montpellier, France

    Alain Bonafé

  4. Department of Radiology, Besançon University Hospital, Besançon, France

    Alessandra Biondi

  5. Department of Neuroradiology, Nantes University Hospital, Nantes, France

    Hubert Desal

  6. Department of Neuroradiology, Nancy University Hospital, Nancy, France

    Serge Bracard

  7. Department of Interventional Neuroradiology, Dupuytren University Hospital, Limoges, France

    Charbel Mounayer

  8. Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Lyon, France

    Francois Chapuis & Laure Huot

  9. Department of Pharmacy, Hospices Civils de Lyon, Délégation à la Recherche Clinique et à l’Innovation, Cellule Innovation, Lyon, France

    Xavier Armoiry

Authors
  1. Francis Turjman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Olivier Levrier
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Xavier Combaz
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Alain Bonafé
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Alessandra Biondi
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Hubert Desal
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Serge Bracard
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Charbel Mounayer
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Roberto Riva
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Francois Chapuis
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Laure Huot
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Xavier Armoiry
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Benjamin Gory
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Francis Turjman.

Additional information

Site investigators and coordinators

Francis Turjman, MD, PhD (Hospices Civils de Lyon, Hôpital Pierre Wertheimer); Nader Sourour, MD (APHP, Hôpital la Pitié Salpetrière); Jacques Moret, MD, Laurent Spelle, MD, PhD, Jildaz Caroff, MD, Léon Ikka, MD (APHP, Hôpital Beaujon); Alessandra Biondi, MD, PhD (CHU Besançon); Xavier Barreau, MD, Jerome Berge, MD (CHU Bordeaux); Patrick Courtheoux, MD (CHU Caen); Frédéric Ricolfi, MD, PhD (CHU Dijon); Charbel Mounayer, MD, PhD (CHU Limoges); Hervé Brunel, MD (CHU Marseille); Olivier Levrier, MD, PhD (Hôpital privé Clairval); Alain Bonafé, MD, PhD (CHU Montpellier); Serge Bracard, MD, PhD (CHU Nancy); Hubert Desal, MD, PhD (CHU Nantes); Stéphane Velasco, MD, Samy Boucebci, MD, Thomas Rocher, MD (CHU Poitiers); Laurent Pierot, MD, PhD (CHU Reims); Jean-Yves Gauvrit, MD, PhD (CHU Rennes); Rémy Beaujeux, MD (CHU Strasbourg); Christophe Cognard, MD, PhD, Anne-Christine Januel, MD (CHU toulouse); Denis Herbreteau, MD (CHU Tours); Michel Piotin, MD, PhD (Fondation Rothschild)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Turjman, F., Levrier, O., Combaz, X. et al. EVIDENCE Trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms. Neuroradiology 57, 49–54 (2015). https://doi.org/10.1007/s00234-014-1439-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00234-014-1439-7

Keywords

Search

Navigation