CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms (CLEVER)

MicroVention

Status: Completed

Conditions: Brain Aneurysm

Treatments: Device: WEB Aneurysm Embolization System

Study type: Observational

Funder types: Industry

Identifiers

NCT03844334

CIP EMEA 18-02

Details and patient eligibility

About

The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

Full description

All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.

Subjects will be followed per Institution's standard of care.

Enrollment: 163 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must be ≥ 18 years of age and ≤80 years of age
2. Subject must have an intracranial aneurysm (IA),
3. Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
4. For ruptured aneurysm, Subject with Hunt & Hess Score ≤ III

Exclusion criteria

1. Subject has an IA with characteristics unsuitable for endovascular treatment
2. Subject's index IA was previously treated
3. Subject has stroke-in-evolution within the prior 30 days
4. An additional aneurysm must be treated during the procedure