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The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

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  • Adam S Arthur
  • Andy Molyneux
  • Alexander L Coon
  • Isil Saatci
  • Istvan Szikora
  • Feyyaz Baltacioglu
  • Ali Sultan
  • Daniel Hoit
  • Josser E Delgado Almandoz
  • Lucas Elijovich
  • Saru Cekirge
  • James V Byrne
  • David Fiorella
  • Markus Holtmannspötter (Medlem af forfattergruppering)
  • WEB-IT Study investigators
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INTRODUCTION: The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.

METHODS: One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.

RESULTS: One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study-a delayed ipsilateral parenchymal hemorrhage-on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.

CONCLUSIONS: The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.

TRIAL REGISTRATION NUMBER: NCT02191618.

OriginalsprogEngelsk
TidsskriftJournal of NeuroInterventional Surgery
Vol/bind11
Udgave nummer9
Sider (fra-til)924-930
Antal sider7
ISSN1759-8478
DOI
StatusUdgivet - 1 sep. 2019

Bibliografisk note

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

ID: 58224825