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Coronary Bifurcations With Ischaemia and Flow Assessment

NCT06971718 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2025-05-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • University of East Anglia

    lead OTHER

Principal Investigators

  • Vassilios S Vassiliou · Norwich Medical School

  • Simon C Eccleshall · Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06971718 on ClinicalTrials.gov