TY - JOUR
T1 - The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms
T2 - final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study
AU - Arthur, Adam S
AU - Molyneux, Andy
AU - Coon, Alexander L
AU - Saatci, Isil
AU - Szikora, Istvan
AU - Baltacioglu, Feyyaz
AU - Sultan, Ali
AU - Hoit, Daniel
AU - Delgado Almandoz, Josser E
AU - Elijovich, Lucas
AU - Cekirge, Saru
AU - Byrne, James V
AU - Fiorella, David
AU - WEB-IT Study investigators
A2 - Holtmannspötter, Markus
N1 - © 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.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - 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.
AB - 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.
KW - Aneurysm
KW - Blood flow
KW - Coil
KW - Device
KW - Magnetic resonance angiography
UR - http://www.scopus.com/inward/record.url?scp=85064516139&partnerID=8YFLogxK
U2 - 10.1136/neurintsurg-2019-014815
DO - 10.1136/neurintsurg-2019-014815
M3 - Journal article
C2 - 30992395
SN - 1759-8478
VL - 11
SP - 924
EP - 930
JO - Journal of NeuroInterventional Surgery
JF - Journal of NeuroInterventional Surgery
IS - 9
ER -