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CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter
Laurent Spelle1,2, Denis Herbreteau3, Jildaz Caroff4,5
1NEURI Brain Vascular Center, Interventional Neuroradiology, Bicetre University Hospital, Le Kremlin-Bicetre, France laurent@spelle.fr.
Insights
The Woven EndoBridge (WEB) device offers safe and effective endovascular treatment for ruptured bifurcation aneurysms, demonstrating good occlusion rates at 1-year follow-up. This approach provides reliable protection against rebleeding in patients with these complex cerebrovascular conditions.
Area of Science:
- Neurosurgery
- Interventional Neuroradiology
- Vascular Surgery
Background:
- The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study previously established the safety and efficacy of the Woven EndoBridge (WEB) device for ruptured bifurcation aneurysms.
- The study demonstrated protection against rebleeding at 1-month and 1-year follow-up, highlighting the importance of 12-month angiographic assessment.
Purpose of the Study:
- To evaluate the 12-month angiographic outcomes of endovascular treatment for ruptured bifurcation aneurysms using the Woven EndoBridge (WEB) device.
- To assess the occlusion rates and safety profile of the WEB device in this patient cohort.
Main Methods:
- A prospective, multicenter study involving 60 patients with 60 ruptured bifurcation aneurysms across 13 European centers.
- Independent assessment of safety outcomes and imaging, with 46 patients undergoing 12-month follow-up imaging.
Main Results:
- At 1-year, complete occlusion (Raymond-Roy grade I) was achieved in 41.3% (19/46) of aneurysms, with residual neck in 45.7% (21/46) and residual aneurysm filling in 13.0% (6/46).
- Adequate occlusion, defined as grade I or II, was reported in 87% (40/46) of aneurysms. Six patients required retreatment.
- The majority of treated aneurysms (88.3%) had a broad base and a low dome-to-neck ratio (<2).
Conclusions:
- The Woven EndoBridge (WEB) device provides effective endovascular treatment for ruptured bifurcation aneurysms, with a favorable safety profile and protection against rebleeding.
- The 1-year angiographic occlusion rates achieved with the WEB device are comparable to those reported in studies of unruptured aneurysms.
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.
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