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CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study.


ABSTRACT:

Background

The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study.

Methods

The CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging.

Results

Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond-Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment.

Conclusions

The CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.

SUBMITTER: Spelle L 

PROVIDER: S-EPMC10314057 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study.

Spelle Laurent L   Herbreteau Denis D   Caroff Jildaz J   Barreau Xavier X   Ferré Jean-Christophe JC   Fiehler Jens J   Januel Anne-Christine AC   Costalat Vincent V   Liebig Thomas T   Bourcier Romain R   Möhlenbruch Markus A MA   Berkefeld Joachim J   Weber Werner W   Mihalea Cristian C   Ikka Léon L   Ozanne Augustin A   Cognard Christophe C   Narata Ana Paula AP   Bibi Richard Edwige RE   Gauvrit Jean-Yves JY   Raoult Hélène H   Velasco Stéphane S   Buhk Jan-Hendrik JH   Chalumeau Vanessa V   Bester Maxim M   Desal Hubert H   du Mesnil de Rochemont Richard R   Bohner Georg G   Fischer Sebastian S   Gallas Sophie S   Biondi Alessandra A   Grimaldi Lamiae L   Moret Jacques J   Byrne James J   Pierot Laurent L  

Journal of neurointerventional surgery 20220726 7


<h4>Background</h4>The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study.<h4>Methods</h4>The CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients wit  ...[more]

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