Article Text

Download PDFPDF

P073/162  Clever: clinical evaluation of WEB 0.017 device in intracranial aneurysms. Final results for ruptured and enraptured aneurysms at 12 months
  1. Istvan Szikora1,
  2. Christophe Cognard2,
  3. Vincent Costalat3,
  4. Fritz Wodarg4,
  5. Denis Herbreteau5,
  6. Sebastian Fischer6,
  7. Markus Möhlenbruch7,
  8. Papagiannaki Chrysanti8,
  9. Joachim Klisch9,
  10. Riitta Rautio10,
  11. Numminen Jussi11,
  12. Berlis Ansgar12,
  13. Jonathan Downer13,
  14. Maxim Bester14,
  15. Stephane Velasco15,
  16. Thomas Liebig16,
  17. James Byrne17,
  18. Laurent Pierot18,
  19. Laurent Spelle19
  1. 1National Institute of Mental Health, Neurology and Neurosurgery , Neurointerventions , Budapest , Hungary
  2. 2CHU Toulouse, Toulouse, France
  3. 3CHU Montpellier, Montpellier, France
  4. 4Universitätsklinikum Schleswig-Holstein, Neuroradiology , Kiel, Germany
  5. 5CHU Tours, Tours , France
  6. 6Universitätsklinikum Knappschaftskrankenhaus , Bochum , Germany
  7. 7Heidelberg University Hospital, Heidelberg , Germany
  8. 8CHU Rouen, Rouen, France
  9. 9Helios General Hospital, Erfurt , Germany
  10. 10Turku University Hospital, Turku, Finland
  11. 11Helsinki University Hospital, Helsinki , Finland
  12. 12University of Augsburg, Augsburg, Germany
  13. 13University Hospitals Division, Edinburgh, UK
  14. 14University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  15. 15CHU Poitiers, Poitiers, France
  16. 16University Hospital of Munich, Münich, Germany
  17. 17Nuffield Department of Surgical Sciences, Oxford , UK
  18. 18Hôpital Maison-Blanche, Reims, France
  19. 19Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Le Kremlin Bicêtre, France


Introduction WEB is an endovascular device allowing treatment of wide-neck bifurcation aneurysms. WEB 17 has been developed to make easier the treatment and to manage smaller aneurysms.

Aim of Study CLEVER objective is to provide safety and efficacy data on the WEB 0.017 in treatment of ruptured and unruptured bifurcation aneurysms at 12 months.

Methods CLEVER is an observational, prospective multicenter study conducted in 17 European sites.

Data collected are 100% monitored and primary endpoints independently evaluated (adverse events adjudicated by CEA, occlusion rates by Corelab).

Data were analyzed on the full population as well as separately for ruptured and unruptured aneurysm. Sample size calculation is based on objective performance approach for safety and efficacy rates.

Results 163 patients were enrolled with 103 unruptured aneurysms and 60 ruptured aneurysms.

Aneurysms treated were ranging from 2 to 9.2 mm.

The primary safety endpoint, defined as the proportion of patients with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment, was 1.8%.

The primary efficacy endpoint, defined as the 12-month rate of adequate occlusion without retreatment, was 82.2%.

Detailed description of endpoints will be provided with a specific attention to the aneurysm initial presentation (ruptured vs unruptured).

Conclusion These results show good efficacy and safety results at 12 months, and no WEB related mortality, confirming safety and efficacy of WEB 0.017 use in unruptured and ruptured aneurysms.

Disclosure of Interest Istvan Szikora has a consulting agreement with Microvention. I Szikora, Chr Cognard and L Spelle served as research coordinators for the CLEVER study

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.