Pipeline Flex Embolization Device Clinical Study
Research type
Research Study
Full title
Pipeline Flex Embolization Device Clinical Study
IRAS ID
156617
Contact name
Saleh Lamin
Contact email
Sponsor organisation
Covidien
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
The Pipeline Flex Embolization (PFED) device is a commercially available flow diversion device used for the treatment of cerebral aneurysms. The purpose of this post-market study is to assess the acute technical device deployment success rate and safety of PFED in a clinical setting. In addition to deployment success, safety will be assessed based on occurrence of major stroke or neurological death at 30 days post-procedure due to complications related to the PFED. Similarly, device resheathability and redeployment success and other neurological safety events will be assessed.
The first generation Pipeline Embolization device has a technical success rate of 87-100%. The PFED has a new delivery system that allows the physician to reposition and redeploy the device. Although the new PFED device is commercially available, Covidien would like to build upon its body of evidence regarding the technical success rate of the PFED as well as its safety profile.
The duration of the PFLEX study will be approximately 8 months. There will be up to 10 participating centers. To participate in the study, the subject must have already been selected for flow diversion therapy as the appropriate treatment and must meet all inclusion and exclusion criteria as outlined in the protocol. Furthermore, the PFED must be used according to the indication within the approved labelling of the device. Information will be collected for up to 50 deployments of the device in up to 50 subjects across the centers. There will be a follow-up period of 30 days for each enrolled subject. Information pertaining to subject demographics, medical history, pertinent medications, aneurysm characteristics collected from imaging along with any reported adverse events will be collected for each subject enrolled. The information collected will be analysed to determine the technical success rate and review the safety profile of the PFED.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1307
Date of REC Opinion
16 Oct 2014
REC opinion
Further Information Favourable Opinion