Comparing drug-coated balloons and stents for heart artery blockages at branching points

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of drug-coated balloons versus drug-eluting stents in treating coronary bifurcation lesions, which are challenging blockages at branching points of the coronary arteries. Using advanced imaging techniques, the study will create computational models to assess blood flow dynamics before and after treatment. Patients with stable angina, silent ischemia, unstable angina, or NSTEMI will be monitored to determine which treatment option provides better outcomes. The study will involve a follow-up period to gather data on patient recovery and treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Norwich Medical School, University of East Anglia
  Norwich, Norfolk, United Kingdom Recruiting

Study contacts

• Principal investigator: Vassilios S Vassiliou — Norwich Medical School
• Study coordinator: Natasha Corballis, MBBS, MRCP (UK), MSc
• Email: natasha.corballis@nnuh.nhs.uk
• Phone: 01603286286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.