%0 Journal Article
%T CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.
%A Spelle L
%A Costalat V
%A Caroff J
%A Wodarg F
%A Fischer S
%A Herbreteau D
%A Möhlenbruch MA
%A Januel AC
%A Papagiannaki C
%A Klisch J
%A Numminen J
%A Rautio R
%A Berlis A
%A Mihalea C
%A Chalumeau V
%A Downer J
%A Cortese J
%A Ikka L
%A Gallas S
%A Bester M
%A Liebig T
%A Velasco S
%A Grimaldi L
%A Byrne J
%A Szikora I
%A Pierot L
%A Cognard C
%J J Neurointerv Surg
%V 0
%N 0
%D 2024 Jul 11
%M 38991733
%F 8.572
%R 10.1136/jnis-2024-021918
%X <B>BACKGROUND: </B>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.<BR><B>OBJECTIVE: </B>To evaluate angiographic stability at 1 year.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.