CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study

• DOI: 10.1136/neurintsurg-2021-017416
• Publication Date: 2021-09-07T17:22:18Z
• Authors: Laurent Spelle; Denis Herbreteau; Jildaz Caroff; Xavier Barreau; Jean-Christophe F...; Jens Fiehler; Anne-Christine Ja...; Vincent Costalat; Thomas Liebig; Romain Bourcier; Markus Möhlenbruch; Joachim Berkefeld; Werner Weber; Cristian Mihalea; Léon Ikka; Augustin Ozanne; Christophe Cognard; Ana Paula Narata; Richard Edwige Bibi; Jean-Yves Gauvrit; Hélène Raoult; Stéphane Velasco; Jan-Hendrik Buhk; Vanessa Chalumeau; Maxim Bester; Hubert Desal; Richard du Mesnil...; Georg Bohner; Sebastian Fischer; Alessandra Biondi; Lamiae Grimaldi; Jacques Moret; James Byrne; Laurent Pierot
• Keywords: Clinical endpoint; Interim; Interim analysis

Background The primary goal of the CLARYS study is to assess protection against rebleeding when treating ruptured bifurcation aneurysms with Woven EndoBridge (WEB) device. Methods a prospective, multicenter conducted in 13 European centers. Patients were consecutively included between February 2016 and September 2017. endpoint was defined as rate target aneurysm treated WEB within 30 days postprocedure. Secondary endpoints periprocedural postprocedural adverse events, total procedure fluoroscopy times, modified Rankin Scale score at 1 month year. Results Sixty patients 60 be included. A device successfully implanted 93.3%. year 0%. mean time 27.0 min. Twenty-three complications observed 18 resolved without sequelae 16 patients. Two these attributed and/or use WEB, leading procedure/device-related intraoperative complication 3.3%. Overall mortality 1.7% 3.8%, respectively overall morbidity 15% 9.6%, respectively. WEB-related 1-month 1-year Conclusions interim results show that endovascular treatment safe effective and, particular, provides rebleeding. It may induce profound change management aneurysms.