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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

Laurent Spelle 1, 2 Denis Herbreteau 3 Jildaz Caroff 1 Xavier Barreau 4 Jean-Christophe Ferré 5 Jens Fiehler 6 Anne-Christine Januel 7 Vincent Costalat 8 Thomas Liebig 9 Romain Bourcier 10 Markus Möhlenbruch 11 Joachim Berkefeld 12, 13 Werner Weber 14 Cristian Mihalea 1 Léon Ikka 1 Augustin Ozanne 1 Christophe Cognard 7 Ana Paula Narata 3 Richard Edwige Bibi 3 Jean-Yves Gauvrit 15 Hélène Raoult 15 Stéphane Velasco 16 Jan-Hendrik Buhk 17 Vanessa Chalumeau 1 Maxim Bester 6 Hubert Desal 10 Richard Du Mesnil de Rochemont 12 Georg Bohner 18 Sebastian Fischer 14 Alessandra Biondi 19 Lamiae Grimaldi 20 Jacques Moret 2, 1 James Byrne 21 Laurent Pierot 22, 23
Abstract : Background The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. Methods The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. Results Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. Conclusions The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.
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https://www.hal.inserm.fr/inserm-03482251
Contributor : Jean-Christophe Ferré Connect in order to contact the contributor
Submitted on : Wednesday, December 15, 2021 - 5:50:23 PM
Last modification on : Monday, January 17, 2022 - 12:19:15 PM

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Laurent Spelle, Denis Herbreteau, Jildaz Caroff, Xavier Barreau, Jean-Christophe Ferré, et al.. 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. Journal of Neurointerventional Surgery, BMJ Journals, 2021, pp.neurintsurg-2021-017416. ⟨10.1136/neurintsurg-2021-017416⟩. ⟨inserm-03482251⟩

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