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Contact Information:

Natasha Corballis
Natasha.corballis@nnuh.nhs.uk


Vassilios Vassiliou
v.vassiliou@uea.ac.uk


Study Location:

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Be Part of Research - Trial Details - Coronary bifurcations with ischaemia and flow assessment

Coronary bifurcations with ischaemia and flow assessment

Recruiting

Open to: Female / Male

Age: 18 Years - N/A

Medical Conditions

Ischaemic heart diseases


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The coronary arteries are the blood vessels that supply oxygenated blood to the heart muscle, allowing it to pump. When these vessels narrow or block, this can cause angina or heart attacks. This is usually treated with drug eluting stents (a metal scaffold inserted into the vessel). 1 in 5 of these occur at the site of a bifurcation (where the blood vessels branch into two vessels). Treating bifurcations is more challenging and can cause more complications. An alternative way to treat this is a drug coated balloon. This is a special type of balloon that is inflated in the blood vessel. The drug coating on the balloon touches the side of the vessel and this is absorbed into the vessel wall. The balloon is removed so no scaffold is left behind in the vessel. These balloons are recommended for use within a re-narrowed stent or a small vessel narrowing.

We intend to look at drug coated balloons and drug eluting stents in a novel way in a bifurcation narrowing using advanced ways of imaging the vessel. This will generate computer models of blood flow to see if blood flow is more normal in the vessel without the stent in. The way that we do this is by analysing the flow at the initial procedure and then bringing these patients back at 3-6 months to re-assess the blood flow. We will use additional measurements:
1. The size of both branches of the vessel initially and at 3-6 months
2. Flow down the vessel using a special wire after the procedure and at 3-6 months to see if there is any difference between using drug eluting stents or drug coated balloons
3. Presence of angina at 12 months using a questionnaire
We intend to do this for 24 patients.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Aug 2023 01 Oct 2026

Observational and Interventional

Type: Active Monitoring;



You can take part if:



You may not be able to take part if:


- Cardiogenic shock - LVEF < 30% - STEMI (as unable to give informed consent prior to procedure) - eGFR < 30 - Severe asthma contra-indicating the 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Norfolk & Norwich University Hospital
    Colney Lane
    colney
    Norwich
    Norfolk
    NR4 7UY
  • Basildon Hospital
    Nethermayne
    Basildon
    Essex
    SS16 5NL

Natasha Corballis
Natasha.corballis@nnuh.nhs.uk


Vassilios Vassiliou
v.vassiliou@uea.ac.uk



The study is sponsored by University of East Anglia and funded by NIHR Academy .




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for Trial ID: CPMS 56807

Last updated 25 April 2025

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