Coronary Bifurcations With Ischaemia and Flow Assessment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of East Anglia

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

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of East Anglia

Lead sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborator