Authors: Adam S. Arthur, MD, MPH, FAANS, FACS; Andrew Molyneux; Alexander Coon, MD; Isil Saatci, MD; Istvan Szikora, MD; Feyyaz Baltacioglu; Ali Sultan, MD; Daniel Hoit, MD, MPH; Lucas Elijovich, MD; Saruhan Cekirge, MD; James Byrne; David Fiorella, MD, PhD; Josser Delgado Almandoz, MD (Memphis, TN)
Introduction: The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, Investigational Device Exemption (IDE) 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 6 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 (CEA). A Data Monitoring Committee (DMC) provided oversight during the trial to ensure subject safety. Results: One-hundred and forty-eight patients received the WEB implant. One (1, 0.7%) primary safety event (PSE) occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on post-operative day (POD) 22. There were no primary safety events after 30 days through 1 year. At 12-month angiographic follow-up, 77/143 patients (53.9%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) of subjects. Conclusions: The pre-specified 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.