WEB™ Intrasaccular Embolization

CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

"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."

Patients

163

Countries

Germany, France, Finland, UK, Hungary

Clinical Centers

Design

Single arm prospective

Scope

Patients 18-80 y.o.with bifurcation intracranial aneurysls, ruptured or unruptured, H&H<4, eligible to be treated with WEB 17.

Purpose

Assessment of efficacy and safety of WEB 17.

Endpoints

Efficacy:

Adequate occlusion without retreatment at 12 months (assessed by Corelab)

Safety:

Proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment, or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment

Efficacy results

Primary endpoint:

Adequate occlusion without retreatment at 12 months: 82.2% (84.9% for rupt AN and 80.6% for unrupt AN)

At 12 months:

Adequate occlusion: 83.9% (86.5% for ruptured AN and 82.4% for unrupt AN)
Complete occlusion: 62.9% (73.1% for rupt AN and 57.1% for unrupt AN)
Retreatment rate: 2.6%

Safety results

Primary endpoint:

Death of non-accidental cause or major stroke within 30 days or major ipsilateral stroke or death of neurological cause from day 31 to 1 year: 1.8% (3.3% for rupt AN and 1.0% for unrupt AN)

At 1 month: