The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations

Launched by CERIC SÀRL · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for patients with a specific type of heart condition called coronary artery disease, particularly when there are blockages at the branches of the arteries (known as bifurcations). The trial aims to find out if a treatment using drug-coated balloons is just as effective as a traditional approach that involves placing a stent (a tiny tube that keeps the artery open) in these complicated areas. This is important because patients with these bifurcation lesions often have worse outcomes, and the simpler balloon treatment could make the procedure easier and safer.

To participate in this trial, you may be eligible if you have a true bifurcation disease affecting both the main artery and a side branch, with significant blockages leading to symptoms like chest pain. You must be at least 65 years old and meet certain medical criteria, such as having specific levels of artery narrowing. If you join the trial, you will receive one of the two treatments and be followed up to see how well it works for your heart condition. It's crucial to know that this study is not yet recruiting participants, so if you're interested, you may need to wait for it to start.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)
• * Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:
• • ≥70% angiographic MV and SB diameter stenosis
• • Positive non-invasive testing for ischaemia
• • Positive coronary physiology for ischaemia
• * Significant SB as described by diameter stenosis ≥50% and all of the following:
• • SB length ≥73mm
• • SB diameter ≥2.5mm
• • Absence of another SB emerging distally from the MV
• • Non-dominant circumflex artery, if SB is a diagonal branch.
• • Exclusion criteria
• • Patients \<18 years old
• • STEMI \<48 hours
• • Cardiogenic shock
• • Chronic total occlusion involving target bifurcation vessels
• • In-stent restenosis
• • Patient life expectancy \<12 months
• • \>2 other coronary lesions (target or non-target) planned for treatment
• • SYNTAX score \>32
• • Platelet count ≤50x109/mm3
• • Left ventricular ejection fraction ≤20%
• • Participation in another investigational drug or device study
• • Patient unable to give informed consent