RecruitingNCT06971718

Coronary Bifurcations With Ischaemia and Flow Assessment

Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation


Sponsor

University of East Anglia

Enrollment

24 participants

Start Date

Oct 10, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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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Interventions

DIAGNOSTIC_TESTOptical coherence tomography and pressure wire assessment of the vessel treated before and after treatment

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.


Locations(1)

Norwich Medical School, University of East Anglia

Norwich, Norfolk, United Kingdom

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NCT06971718


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