Ilumien III
Research type
Research Study
Full title
Optical Coherence Tomography (OCT) compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter Randomized Trial in PCI - Ilumien III/Optimize PCI
IRAS ID
182757
Contact name
Jonathan Hill
Contact email
Sponsor organisation
St. Jude Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 1 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 /narrrowed arteries to help open them up.
This study is a prospective, post market, international, multi-centre randomised trial. Patients undergoing coronary angiography with the posibility of Percuntaenous coronary intervention (PCI) will be recruited to the study.
The purpose of this study is to compare the use of three 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 3 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) Intravascular Ultrasound (IVUS) - This method uses ultrasound technology to generate pictures of the arteries.
(3) 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 and 1 year.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1218
Date of REC Opinion
7 Aug 2015
REC opinion
Favourable Opinion