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.
Study Type
OBSERVATIONAL
Enrollment
24
OCT 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.
Norwich Medical School, University of East Anglia
Norwich, Norfolk, United Kingdom
RECRUITINGPhysiological assessment
Physiological assessment measuring: * FFR (Main vessel and side branch) * Wall sheer stress
Time frame: 3-9 months
OCT derived anatomical measure
Mean lumen area main vessel and mean lumen area side branch
Time frame: 3-9 months
Late lumen loss
Angiographic assessment of late lumen loss in main vessel and side branch
Time frame: 3-9 months
Device oriented clinical endpoints
Composite of: * Cardiovascular death * Device failure related MI * Device failure related ischaemia * Target bifurcation revascularisation
Time frame: 3-9 months
Patient focused endpoint: Angina
Seattle angina questionnaire
Time frame: 12 months
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