Comparing drug-coated balloons and stents for heart artery blockages at branching points
Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation
This study is testing whether drug-coated balloons or drug-eluting stents work better for treating tough blockages in heart arteries where they branch, focusing on patients with different types of heart issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of East Anglia Academic / other |
| Locations | 1 site (Norwich, Norfolk) |
| Trial ID | NCT06971718 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with specific bifurcation lesions suitable for a provisional main vessel treatment strategy.
Not a fit: Patients experiencing cardiogenic shock, severe heart failure, or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with complex coronary artery blockages.
How similar studies have performed: Other studies have shown promising results with drug-coated balloons in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Norwich, Norfolk
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.