NV-PMK-1502 BRAVO PMCF
Research type
Research Study
Full title
A Prospective, Multi-center, Single Arm Post-Market Clinical Follow-Up Study to evaluate the effectiveness of the BRAVO(TM) Flow diverter in the endovascular treatment of intracranial aneurysms
IRAS ID
253688
Contact name
Saleh Lamin
Contact email
Sponsor organisation
Cerenovus, part of DePuy Synthes Products, Inc
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
The BRAVO PMCF study is a prospective, multi-center, single arm, post-market clinical follow up study that will be conducted in 20 institutes in Europe. A target of 117 subjects will be enrolled. Subjects will be followed for a total of 1 year.
The purpose of this study is to gather information on the CERENOVUS BRAVOTM Flow Diverter (FD) Device. This study is required as part of the study Sponsor’s commitment to monitor the safety and performance of this device after it has been placed on the market for use.
The primary objective is to evaluate the achievement of complete aneurysm occlusion by the BRAVOTM Flow Diverter in the endovascular treatment of intracranial aneurysm in the real life clinical setting at 1 year post-treatment. The secondary objectives include the evaluation of treatment and safety outcomes over the 1 year follow-up period for subjects treated with the device.The study is expected to take place in approximately 20 institutions within Europe. About 117 people with a non-ruptured intracranial aneurysm will take part in this study. Each participant will receive the BRAVOTM FD device.
Patients eligible for the trial will be invited to participate by the investigator at the study site. They will be asked to sign the informed consent form before study participation.
The following visits and study procedures are planned during this study:
- Screening / baseline
- Procedure
- Follow up visits at
o Discharge
o 30 days after the procedure (telephone call)
o 6 months after the procedure (clinic visit)
o 12 months after the procedure (clinic visit)
During all visits, the overall health status of the patient will be assessed (including review of any potential adverse events and changes in medication) and the patient’s disability or dependence in activities of daily living will be assessed using the Modified Rankin Scale.
At 6 months and 12 months after the procedure, images of the brain will be taken (DSA or MRA at 6 months, DSA at 12 months). All images obtained during this study will be sent to a central laboratory for review.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0315
Date of REC Opinion
12 Dec 2019
REC opinion
Further Information Favourable Opinion