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.
Publication/Presentation Date
9-1-2019
Abstract
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.
Volume
11
Issue
9
First Page
924
Last Page
930
ISSN
1759-8486
Published In/Presented At
Arthur, A. S., Molyneux, A., Coon, A. L., Saatci, I., Szikora, I., Baltacioglu, F., Sultan, A., Hoit, D., Delgado Almandoz, J. E., Elijovich, L., Cekirge, S., Byrne, J. V., Fiorella, D., & WEB-IT Study investigators (2019). 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. Journal of neurointerventional surgery, 11(9), 924–930. https://doi.org/10.1136/neurintsurg-2019-014815
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
30992395
Department(s)
Administration and Leadership
Document Type
Article