Actively Recruiting

Age: 18Years +
All Genders
NCT06971718

Coronary Bifurcations With Ischaemia and Flow Assessment

Led by University of East Anglia · Updated on 2025-05-14

24

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

Sponsors

U

University of East Anglia

Lead Sponsor

N

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Coronary Bifurcations With Ischaemia and Flow Assessment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or over
  • Any bifurcation lesion suitable for a provisional main vessel treatment strategy
  • Main vessel diameter of 2.5 mm or more and side branch diameter larger than 2 mm
  • Diagnosis of stable angina, silent ischaemia, unstable angina, or NSTEMI
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Cardiogenic shock
  • Left ventricular ejection fraction less than 30%
  • STEMI (unable to give informed consent)
  • Estimated glomerular filtration rate less than 30
  • Severe asthma preventing the use of adenosine
  • High degree AV block on ECG preventing the use of adenosine
  • Pregnancy
  • Unable to give informed consent
  • Left main stem coronary bifurcation lesions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Norwich Medical School, University of East Anglia

Norwich, Norfolk, United Kingdom, NR47TJ

Actively Recruiting

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Research Team

N

Natasha Corballis, MBBS, MRCP (UK), MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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