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.

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.

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: JF acts as associate editor of the Journal of NeuroInterventional Surgery; MM acts as a member of the editorial board of Neuroradiology. LS: consultant for Microvention, Balt, Phenox, Stryker, Medtronic, PI for CLARYS, grant or contract from Philips with institution; DH: consultant for Microvention; XB: consultant for Microvention; JF: Consultant for Medtronic, Microvention, and Cerus; VCo: consultant for Microvention, educational grant and research grant with payment to institution; TL: consultant for Microvention/Sequent Medical, Stryker, Medtronic, and Cerus; MM: consultant and expert testimony for Medtronic, Microvention, and Stryker with payment to institution; WW: payment or honoraria for proctoring and lectures from Microvention; CC: consultant for Microvention, MIVI, Stryker, and Cerenovus; J-HB: payment or honoraria for proctoring and lectures from Microvention; MB: consultant for Microvention, Cerenovus, Acandis, and Rapid; GB: support for travel from Microvention; SF: honoraria for lecture and data preparations regarding WEB; AB: consultant for Microvention; JM: consultant for Microvention. LP: consultant for Microvention, Balt, Perflow, Phenox, Vesalio, clinical event adjudicator for CLARYS; JBy: core laboratory reviewer for CLARYS.