The Oxford Optimisation of PCI Study (OXOPT-PCI study).
Research type
Research Study
Full title
Multimodal Assessment to Optimise the Result of Percutaneous Coronary Interventions.
IRAS ID
204681
Contact name
Adrian/ AB Banning
Contact email
Sponsor organisation
Oxford University Hospitals NHS Trust
Clinicaltrials.gov Identifier
16/SC/0362, REC Nr
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This study aims to improve the outcome of stent procedures for patients with angina caused by narrowed or blocked vessels taking blood to the heart muscle.
The OxOPT-PCI study addresses patients with coronary artery disease who are referred to the John Radcliffe Hospital because of the need for treatment with an intra-coronary stent (metal scaffold) for clinical reasons. Although, this has become a highly standardised procedure it is still challenging for the clinician to assess the final success of this procedure at the end of intervention with conventional methods. This shortcoming can potentially translate into a worse clinical outcome for approximately 10 percent of all patients treated with an intra-coronary stent for this type of disease.
This study (OxOPT-PCI) investigates if the use of blood flow measurements (namely measurement of fractional flow reserve (FFR)) and intravascular imaging (namely optical coherence tomography (OCT)) after the implantation of a stent can improve the treatment result for these patients. Both, FFR and OCT are being used already in daily clinical routine but their usefulness to guide optimisation of the stenting procedure, especially in combination is not clear. In order to standardise the optimisation procedure we developed a specific algorithm to make sure that all patients receive the same optimisation measures based on the assessment of FFR and OCT.
The benefit of this specific optimisation algorithm will be assessed by measuring 1) indices of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by contacting the patients 12 months after stentimplantation to verify the clinical mid-term success.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0394
Date of REC Opinion
9 Aug 2016
REC opinion
Further Information Favourable Opinion