PT - JOURNAL ARTICLE AU - Adam S Arthur AU - Andy Molyneux AU - Alexander L Coon AU - Isil Saatci AU - Istvan Szikora AU - Feyyaz Baltacioglu AU - Ali Sultan AU - Daniel Hoit AU - Josser E Delgado Almandoz AU - Lucas Elijovich AU - Saru Cekirge AU - James V Byrne AU - David Fiorella ED - , TI - 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 AID - 10.1136/neurintsurg-2019-014815 DP - 2019 Sep 01 TA - Journal of NeuroInterventional Surgery PG - 924--930 VI - 11 IP - 9 4099 - http://jnis.bmj.com/content/11/9/924.short 4100 - http://jnis.bmj.com/content/11/9/924.full SO - J NeuroIntervent Surg2019 Sep 01; 11 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