CLEVER study
Research type
Research Study
Full title
CLEVER - Clinical Evaluation of WEB 0.017 device in Intracranial Aneurysms
IRAS ID
259907
Contact name
Habib Nacer-Cherif
Contact email
Sponsor organisation
MicroVention Europe, A TERUMO Group Company
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 8 months, 3 days
Research summary
This is an observational non-randomized, European, multi-centre, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System
in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.
The aim of the study is to further investigate the utility of an already tested medical device which is used for the treatment of aneurysms in the brain. An aneurysm is an area in which a blood vessel bulges out because the vessel‘s wall is too weak.
The medical device used in this study is designed to disrupt the flow of blood into the aneurysm so that the blood starts to clot and a blood clot can form inside the device ("endovascular embolization"). Endovascular embolization is a medical procedure to treat aneurysms with the medical device from the inside of the blood vessel. Hereby blood clotting is used to prevent the blood from continuing to flow inside the bulge so that the vessel wall is protected, and no bleeding occurs.
Patient enrolment will be a minimum of 160 subjects with aneurysms (around 100 unruptured and 60 ruptured).
In the treatment group, the WEB embolization device will be intended to be used alone to treat the target aneurysm. Follow-up evaluations will be done at 30 days (office visit or telephone call) and interim visits will occur between 3 and 6 months and at 12 months (- 3 months and + 6 months) post-treatment per standard of care at the hospital.
It is expected that 160 patients at up to 20 hospitals in Europe will participate in the study.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0053
Date of REC Opinion
2 May 2019
REC opinion
Further Information Favourable Opinion