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
This trial does not accept healthy volunteersQualifiers
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 population
Any patient with coronary bifurcation lesion who fulfills the inclusion criteria and is not precluded by the exclusion criteria is suitable for recruitment.
Trial design
Other
Prospective
Treatments tested in this trial
Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment
Diagnostic testOCT and pressure wire of the main vessel and side branch of the bifurcation are undertaken prior to and after treating the lesion and at 3-9 month follow up.
Treatment groups
Trial outcomes
Primary outcomes
Physiological assessment
Physiological assessment measuring: * FFR (Main vessel and side branch) * Wall sheer stress
OCT derived anatomical measure
Mean lumen area main vessel and mean lumen area side branch
Secondary outcomes
Late lumen loss
Angiographic assessment of late lumen loss in main vessel and side branch
Device oriented clinical endpoints
Composite of: * Cardiovascular death * Device failure related MI * Device failure related ischaemia * Target bifurcation revascularisation
Patient focused endpoint: Angina
Seattle angina questionnaire
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of East Anglia
Lead sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator