COMET
Research type
Research Study
Full title
Boston Scientific COMET Wire Validation Study
IRAS ID
188995
Contact name
Nicholas Curzen
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT02578381, ClinicalTrials.gov
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
Evidence is available indicating the most effective treatment plans for patients who undergo a coronary angiogram are likely to be achieved if there is clinical data available regarding the presence of patient-specific and lesion-specific ischaemia. Anatomical information is obtained via the coronary angiogram whereas the intracoronary pressure wire (PW) provides information as to whether coronary narrowings found at angiography are flow limiting (ischaemic) and require revascularisation.
This study will evaluate the performance of a new CE marked PW manufactured by Boston Scientific(BSPW). The BSPW will be independently and objectively validated in this study taking the performance of the currently available St Jude Medical pressure wire (SJPW) as the reference, using both inter-wire and intra-wire measurements. Thus not only will the study assess the reproducibility of the measurements between the 2 wires but will also compare reproducibility of measurements from 2 wires of the same manufacturer.
REC name
Wales REC 7
REC reference
15/WA/0384
Date of REC Opinion
25 Feb 2016
REC opinion
Further Information Favourable Opinion