Coronary bifurcations with ischaemia and flow assessment
Research type
Research Study
Full title
Drug coated balloons in coronary bifurcation lesions. A feasibility study looking at computational flow dynamics, ischaemia and anatomical changes to the bifurcation
IRAS ID
325142
Contact name
V Vassiliou
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The coronary arteries are the blood vessels that supply oxygenated blood to the heart muscle, allowing it to pump. When these vessels narrow or block, this can cause angina or heart attacks. This is usually treated with drug eluting stents (a metal scaffold inserted into the vessel). 1 in 5 of these occur at the site of a bifurcation (where the blood vessels branch into two vessels). Treating bifurcations is more challenging and can cause more complications. An alternative way to treat this is a drug coated balloon. This is a special type of balloon that is inflated in the blood vessel. The drug coating on the balloon touches the side of the vessel and this is absorbed into the vessel wall. The balloon is removed so no scaffold is left behind in the vessel. These balloons are recommended for use within a re-narrowed stent or a small vessel narrowing.
We intend to look at drug coated balloons and drug eluting stents in a novel way in a bifurcation narrowing using advanced ways of imaging the vessel. This will generate computer models of blood flow to see if blood flow is more normal in the vessel without the stent in. The way that we do this is by analysing the flow at the initial procedure and then bringing these patients back at 3-6 months to re-assess the blood flow. We will use additional measurements:
1. The size of both branches of the vessel initially and at 3-6 months
2. Flow down the vessel using a special wire after the procedure and at 3-6 months to see if there is any difference between using drug eluting stents or drug coated balloons
3. Presence of angina at 12 months using a questionnaire
We intend to do this for 24 patients.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
23/WM/0129
Date of REC Opinion
11 Jul 2023
REC opinion
Further Information Favourable Opinion