ILUMIEN IV: OPTIMAL PCI
Research type
Research Study
Full title
OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI
IRAS ID
242628
Contact name
Jonathan Hill
Contact email
Sponsor organisation
Abbott Vascular (formerly St Jude Medical)
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
5 years, 0 months, 7 days
Research summary
Coronary Artery Disease is the narrowing or blockage of the coronary arteries, usually caused by the build-up of cholesterol and fatty deposits in the walls of the arteries. This blockage can slow down the blood flow carrying oxygen and vital nutrients to the heart and in turn cause chest pain and potentially a heart attack.
A Coronary Angiogram shows an image of the coronary arteries and is used to check if there are any narrowing/ blockages. A possible treatment for this is called percutaneous coronary intervention (PCI) where a stent is implanted in the blocked /narrowed arteries to help open them up.
This study is a prospective, single-blind, international, multi-centre randomised trial. Patients undergoing coronary angiography with the possibility of Percutaneous coronary intervention (PCI) will be recruited to the study.
The purpose of this study is to compare the use of two imaging methods to assess how they influence the decision making process for coronary stent implantation
Patients who are eligible to participate will be randomised to one of the 2 imaging groups below while undergoing a routine PCI:
(1) Optical Coherence Tomography (OCT) - This method uses light waves to generate a high resolution of images of the inside of the vessels of the heart.
(2) Angiography - Type of x-ray using contrast dye to identify narrowed/blocked blood vessels.
After hospital discharge, all patients will have a clinical follow up at 30 days 1 year and 2 years.
Once patients have provided consent to be part of the study, they will adhere to the requirements of the study protocol. All procedures required by the protocol are routine standard of care and participation in this trial carries no additional risk to the patient.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1193
Date of REC Opinion
21 Sep 2018
REC opinion
Further Information Favourable Opinion