Purpose WEB Flow disruption is an innovative endovascular treatment for wide-neck bifurcation aneurysms. Two prospective multicenter GCP (Good Clinical Practice) studies were conducted in Europe and inclusions were completed in February 2014 in both trials. Safety and efficacy data are analyzed.
Methods Patients with wide neck bifurcation aneurysms were included in both WEBCAST and French Observatory. An independent medical monitor independently analyzed adverse events. Follow-up imaging was obtained at 6 and 12 months in WEBCAST study and at 12 months in French Observatory. An independent expert in Interventional Neuroradiology evaluated anatomical results using the 3 grades scale: complete occlusion, neck remnant, and aneurysm remnant. In WEBCAST, the reader was also directly comparing evolution of anatomical results between 6 months and 12 months classified as improved, stable, or worsened.
Results A total of 113 patients (74 females, 65.5%) with 114 aneurysms (10 ruptured, 8.8%; 99 unruptured, 88.8%; and 5 recanalized, 4.4%) were included in both studies (51 in WEBCAST and 62 in French Observatory). Fifty-nine aneurysms were located at middle cerebral artery (51.8%), 22 at anterior communicating artery (19.3%), 21 at basilar artery (18.4%), and 12 at internal carotid artery terminus (10.5%). Morbidity and mortality at one month were respectively 2.7% and 0.0%.
Twelve months imaging follow-up will be completed in 2015, is currently under analysis, and will be presented as well as evolution of aneurysm occlusion between 6 and 12 months in WEBCAST.
Conclusion This analysis confirms the safety of WEB treatment. Efficacy data will be presented.
Disclosures L. Pierot: 2; C; Sequent. A. Molyneux: 2; C; Sequent. J. Byrne: 2; C; Sequent.
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