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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Bifurcation Lesions
• Intervention / Treatment: Diagnostic test: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Natasha Corballis, MBBS, MRCP (UK), MSc; Phone Number: 01603286286; Email: natasha.corballis@nnuh.nhs.uk

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR47TJ
      • Recruiting
      • Norwich Medical School, University of East Anglia
      • Contact: Natasha Corballis; Phone Number: 01603286286; Email: natasha.corballis@nnuh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient with coronary bifurcation lesion who fulfills the inclusion criteria and is not precluded by the exclusion criteria is suitable for recruitment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Drug eluted stent	Diagnostic test: Optical 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.; Other Names: Optical coherence tomography
Drug coated balloon	Diagnostic test: Optical 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.; Other Names: Optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological assessment	Physiological assessment measuring: FFR (Main vessel and side branch); Wall sheer stress	3-9 months
OCT derived anatomical measure	Mean lumen area main vessel and mean lumen area side branch	3-9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late lumen loss	Angiographic assessment of late lumen loss in main vessel and side branch	3-9 months
Device oriented clinical endpoints	Composite of: Cardiovascular death; Device failure related MI; Device failure related ischaemia; Target bifurcation revascularisation	3-9 months
Patient focused endpoint: Angina	Seattle angina questionnaire	12 months

Collaborators and Investigators

• Sponsor: University of East Anglia
• Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Vassilios S Vassiliou, Norwich Medical School; Principal Investigator: Simon C Eccleshall, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 6, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Computational flow dynamics; Coronary bifurcation lesions; Drug coated balloons
• Other Study ID Numbers: 325142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No