PEDVU
Research type
Research Study
Full title
Outcome Study of the Pipeline Embolization Device with Vantage Technology in Unruptured Aneurysms (PEDVU)
IRAS ID
317314
Contact name
Thomas Booth
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Research Summary
Stents have been used effectively and safely for many years to treat brain aneurysms. The new generation, called “Pipeline embolization device with Vantage Technology” (PEDV) introduces improved structure when compared to the previous ones and there is currently limited evidence regarding its safety and efficacy. There have been two versions of the PEDV, an initial version and the later commercial one. In this pragmatic and non-industry funded study, we demonstrate clinical and radiographic (safety and efficacy) outcomes of the new generation commercial (second) version of PEDV for the first time. We also compare different imaging modalities to detect the best sole follow up imaging modality. For avoidance of doubt there is no additional intervention (whether related to treatment or imaging) in this study which follows standard of care.
Summary of Results
For unruptured aneurysm treatment, the second PEDV version appears to have superior efficectiveness and a similar safety profile to previous-generation PEDs. These are acceptable outcomes in this pragmatic and non-industry-sponsored study.
Analysis of ruptured aneurysm outcomes is limited by the number of participants.
REC name
Wales REC 3
REC reference
22/WA/0299
Date of REC Opinion
19 Oct 2022
REC opinion
Favourable Opinion