Define PCI
Research type
Research Study
Full title
DEFINE-PCI -Physiologic assessment of coronary stenosis following PCI
IRAS ID
226509
Contact name
Sayan Sen
Contact email
Sponsor organisation
Volcano/Philips
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
DEFINE-PCI is a multi-centre, prospective, observational study in up to 25 centres in USA and internationally. Consented subjects with coronary artery disease who undergo physiologic lesion assessment with an iFR (instantaneous wave-free ratio) value below 0.90 (a positive reading) in at least 1 coronary artery are eligible for participation. After successful percutaneous coronary intervention (PCI, or stenting) to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischaemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0291
Date of REC Opinion
21 Jun 2017
REC opinion
Further Information Favourable Opinion