Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck
aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging
to treat with previously developed technologies. The Woven EndoBridge (WEB) device
has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms.The
CLEVER study was an observational, multicenter, prospective study conducted in 17
European investigational sites using the WEB 17 device, for the treatment of ruptured
and unruptured aneurysms. The study objective was to provide safety and efficacy data
on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging
results were assessed independently by a Corelab and adverse events adjudicated by
a Clinical Event Adjudicator. This analysis reports procedural results and safety
at 30 days and 12 months.A total of 163 patients (mean age 58.1 years; 68.1% women)
with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms
were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral
artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the
mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients
(100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients
(1.8%), and no device-related mortality was observed.Endovascular treatment of ruptured
and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication
rate and no device-related mortality. In particular, none of the ruptured aneurysms
bled again up to 1 year of follow-up.NCT03844334.
