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NCT Number: NCT06971718

Coronary Bifurcations With Ischaemia and Flow Assessment

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.

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Key information

Conditions

Coronary Bifurcation Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwich Medical School, University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location status: Recruiting

Location contact

Natasha Corballis

CONTACT

[email protected]

01603286286

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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.

Other names: Optical coherence tomography

Primary outcomes

  1. Physiological assessment

    Time frame: 3-9 months

    Physiological assessment measuring:

    • FFR (Main vessel and side branch)
    • Wall sheer stress

  2. OCT derived anatomical measure

    Time frame: 3-9 months

    Mean lumen area main vessel and mean lumen area side branch

Secondary outcomes

  1. Late lumen loss

    Time frame: 3-9 months

    Angiographic assessment of late lumen loss in main vessel and side branch

  2. Device oriented clinical endpoints

    Time frame: 3-9 months

    Composite of:

    • Cardiovascular death
    • Device failure related MI
    • Device failure related ischaemia
    • Target bifurcation revascularisation

  3. Patient focused endpoint: Angina

    Time frame: 12 months

    Seattle angina questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Natasha Corballis, MBBS, MRCP (UK), MSc

CONTACT

[email protected]

01603286286

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Collaborators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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