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.To evaluate angiographic stability
at 1 year.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.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.
