CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms

Spelle, L; Costalat, V; Caroff, J; Wodarg, F; Fischer, S; Herbreteau, D; Möhlenbruch, MA; Januel, A; Papagiannaki, C; Klisch, J; Numminen, J; Rautio, R; Berlis, A; Mihalea, C; Chalumeau, V; Downer, J; Cortese, J; Ikka, L; Gallas, S; Bester, M; Liebig, T; Velasco, S; Grimaldi, L; Byrne, J

Journal article

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms

Abstract:: Background: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year. Objective: To evaluate angiographic stability at 1 year. Methods: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design. Results: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms Conclusion: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.

Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Spelle, L., Costalat, V., Caroff, J., Wodarg, F., Fischer, S., Herbreteau, D., Möhlenbruch, M. A., Januel, A., Papagiannaki, C., Klisch, J., Numminen, J., Rautio, R., Berlis, A., Mihalea, C., Chalumeau, V., Downer, J., Cortese, J., Ikka, L., Gallas, S., … Byrne, J. (2024). CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms. Journal of NeuroInterventional Surgery.

MLA Style

Spelle, L, et al. “CLinical EValuation of WEB 17 Device in Intracranial AneuRysms (CLEVER): 1-Year Effectiveness Results for Ruptured and Unruptured Aneurysms.” Journal of NeuroInterventional Surgery, 2024.

Chicago Style

Spelle, L, V Costalat, J Caroff, et al. 2024. “CLinical EValuation of WEB 17 Device in Intracranial AneuRysms (CLEVER): 1-Year Effectiveness Results for Ruptured and Unruptured Aneurysms.” Journal of NeuroInterventional Surgery.
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