{Reference Type}: Journal Article
{Title}: CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.
{Author}: Spelle L;Costalat V;Caroff J;Wodarg F;Fischer S;Herbreteau D;Möhlenbruch MA;Januel AC;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;Szikora I;Pierot L;Cognard C;
{Journal}: J Neurointerv Surg
{Volume}: 0
{Issue}: 0
{Year}: 2024 Jul 11
{Factor}: 8.572
{DOI}: 10.1136/jnis-2024-021918
{Abstract}: <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.