The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coate… (NCT06822322) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations
750 participantsStarted 2025-05
Plain-language summary
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.