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

Abstract

BackgroundThe 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.MethodsThe 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.ResultsSixty 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.ConclusionsThe 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.

Aneurysm Treatment with Woven EndoBridge-17: Angiographic and Clinical Results at 12 Months from a Retrospective, 2-Center Series

“…In the CLARYS study, 21 12-month anatomic results were slightly different compared with the present series, with a lower rate of complete aneurysm occlusion (41.3%) and higher rates of neck (45.7%) and aneurysm (13.0%) remnants. However, the rate of adequate occlusion was higher (87.0%).…”

“…18 In parallel to the technical evolution of the WEB device, its indications progressively enlarged to distal and sidewall aneurysms. [11][12][13] Several multicenter prospective series, including WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST), 3 WEBCAST 2, 5 French Observatory, 6 WEB Intrasaccular Therapy (WEB-IT), 10 and CLARYS, 21 have demonstrated favorable safety and efficacy of EVT with the WEB device; however, these studies were conducted before the introduction of the 17 system.…”

Utility of low-profile visualized intraluminal support (LVIS™) stent for treatment of acutely ruptured bifurcation aneurysms: A single-center study

“…However, only the Woven EndoBridge device has been approved for clinical use in China but not for treating ruptured intracranial aneurysms. A prospective multicenter assessment of the Woven EndoBridge device in ruptured aneurysms conducted by Spelle et al ( 41 ) presented a complete occlusion rate of 41.3% (19/46) at 1 year follow-up. Another study by Youssef et al ( 42 ) revealed that 61.5% of cases achieved complete occlusion in follow-up.…”

Decoding the data: a comment on the American Heart Association/American Stroke Association (AHA/ASA) 2023 Guideline for the Management of patients with Aneurysmal Subarachnoid Hemorrhage

“…At 1 year, 41.3% of aneurysms were completely occluded (Raymond-Roy Class I; RR I), 45.7% residual neck (RR II), and 13.0% residual aneurysm (RR III) with 13% retreatment rate. 11 While this study did have independent radiographic adjudication, it lacked a randomized comparison treatment group. The World-WideWEB Consortium is an international multicenter cohort including patients with both unruptured and ruptured aneurysms treated with the WEB device.…”