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RECRUITING
NCT06971718

Coronary Bifurcations With Ischaemia and Flow Assessment

Sponsor: University of East Anglia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

24

Start Date

2023-10-10

Completion Date

2026-06-01

Last Updated

2025-05-14

Healthy Volunteers

No

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.

Locations (1)

Norwich Medical School, University of East Anglia

Norwich, Norfolk, United Kingdom