Coronary Bifurcations With Ischaemia and Flow Assessment

NCT06971718 | Recruiting DMC

• 1 other identifier: 325142
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Bifurcation Lesions

Keywords

Drug coated balloons; Coronary bifurcation lesions; Computational flow dynamics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Late lumen loss

  3-9 months

• Device oriented clinical endpoints

  3-9 months

• Patient focused endpoint: Angina

  12 months

Study Arms (2)

Drug eluted stent

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

Drug coated balloon

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

Interventions

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.

Also known as: Optical coherence tomography

Drug coated balloon; Drug eluted stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Norwich Medical School, University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

RECRUITING

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Vassilios S Vassiliou

  Norwich Medical School

  PRINCIPAL INVESTIGATOR

• Simon C Eccleshall

  Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Corballis, MBBS, MRCP (UK), MSc

CONTACT

01603286286; natasha.corballis@nnuh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: October 10, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)