About this trial
The coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. If these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks. Narrowings are usually treated using metal scaffolds called drug eluting stents. However, in one in five cases where the narrowing occurs at a branching point, treating it with stents is more challenging and can cause complications. A possible alternative treatment is using a special type of balloon called a drug-coated balloon. This balloon is inflated in the blood vessel and releases medicine to help widen the blood vessel and the procedure is completed without leaving any metallic scaffold behind.
This study aims to compare drug coated balloons with drug eluting stents to see which treatment works better for narrowing that occurs at branching points. We will used advanced imaging techniques to create computer models of blood flow in the vessels, and we will follow up with patients over tie to see how well the treatments work.
Eligibility criteria
Qualifiers
Age 18 or over
Any bifurcation lesion amenable to a provisional main vessel treatment strategy
A main vessel diameter of 2.5mm or more and side branch diameter of >2mm
Any patient with stable angina, silent ischaemia, unstable angina or NSTEMI
Disqualifiers
Cardiogenic shock
LVEF <30%
STEMI (as unable to give informed consent)
eGFR <30
Trial design
Treatments tested in this trial
- Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment
Treatment groups
Sponsors and collaborators
University of East Anglia
Lead sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator