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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Norwich Medical School, University of East Anglia
RECRUITING
Norwich
Contact Information
Primary
Natasha Corballis, MBBS, MRCP (UK), MSc
natasha.corballis@nnuh.nhs.uk
01603286286
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 24
Treatments
Drug eluted stent
Drug coated balloon
Related Therapeutic Areas
Sponsors
Leads: University of East Anglia
Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov

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