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Coronary Bifurcations With Ischaemia and Flow Assessment

Recruitingn/aAges 18 Years - anyAllUniversity of East Anglia
NCT06971718 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Able to give informed consent Exclusion Criteria: * Cardiogenic shock * LVEF \<30% * STEMI (as unable to give informed consent) * eGFR \<30 * Severe asthma contraindicating use of adenosine * High degree AV block on 12 lead ECG precluding the use of adenosine * Pregnancy * Inability to consent * Left main stem coronary bifurcation lesions
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What it tests

  • Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment
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Where

1 site
Norwich Medical School, University of East Anglia
Norwich, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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