CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.
J Neurointerv Surg
; 2024 Jul 11.
Article
en En
| MEDLINE
| ID: mdl-38991733
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 0.017â³ 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 aneurysmsCONCLUSION:
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.
Texto completo:
1
Bases de datos:
MEDLINE
Idioma:
En
Revista:
J Neurointerv Surg
/
J. neurointerv. surg. (Print)
/
Journal of neurointerventional surgery (Print)
Año:
2024
Tipo del documento:
Article
País de afiliación:
Francia