WEB™ Intrasaccular Embolization

CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms

"The CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms."

Patients

Countries

France

Clinical Centers

Design

Single arm prospective

Scope

Patients 18-80 y.o. with bifurcation ruptured intracranial aneurysms, H&H<4, treatable with WEB only.

Purpose

Assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.

Endpoints

Rebleed rate after treatment during the period extending from post-procedure up to 1 month.

Definitions:

Rebleeding from target aneurysm is defined as patent evidence of hemorrhage on CT or MRI AND hemorrhage is depicted in the same territory as the initial bleeding AND hemorrhage has increased in size compare to initial pre-operative CT
Screening for rebleeding: During hospital stay of the patient and up to 1-month, any worsening of the clinical status should lead to perform a non-enhanced CT or MRI.

Or, as per-center standard care, non-enhanced CT or MRI might be performed systematically during hospital course.