Optimal side-branch stenting strategy for complex coronary bifurcation using drug-coated balloons

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 is a prospective, multi-center, open-label, randomized controlled superiority trial comparing an upfront two-stent strategy versus an upfront DCB-based hybrid strategy in patients with complex true coronary bifurcation lesions. Eligible lesions are true bifurcations (Medina 1,1,1; 1,0,1; 0,1,1) with side-branch lesion length ≥10 mm and defined severity/size thresholds for left main and non-left main vessels. The study enrolls adults undergoing PCI for acute or chronic coronary syndromes and measures clinical outcomes such as mortality, unplanned repeat revascularization, and stent-related complications. The trial builds on mixed prior results favoring two-stent approaches in more complex lesions and emerging data supporting DCB angioplasty at side branches.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Subject must be at least 19 years of age
* Patients with acute or chronic coronary syndrome intended for percutaneous coronary intervention (PCI)
* Patients with de novo complex coronary bifurcation with clinically relevant side branch. Definition of complex coronary bifurcation with clinically relevant side branch is true bifurcation lesion (Medina 1,1,1 / 1,0,1 / 0,1,1) with side branch lesion length ≥10mm and should meet at least one of the below criteria.

  i. Left main bifurcation with side branch stenosis severity ≥70% by visual estimation ii. Non-left main bifurcation with side branch reference vessel diameter ≥2.75mm and stenosis severity ≥90% by visual estimation
* Subject who can verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria

* Hemodynamically unstable condition (SBP \<90 mmHg even after administration of vasopressor, ventricular arrhythmias, or cardiogenic shock)
* Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
* Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms.
* Severe left ventricular systolic dysfunction (ejection fraction \<30%)
* Intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, or heparin.
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Unwillingness or inability to comply with the procedures described in this protocol.

Where it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting
• Chonnam National University Hospital
  Gwangju, South Korea Not yet recruiting
• Chosun University Hospital
  Gwangju, South Korea Not yet recruiting

Study contacts

• Principal investigator: Young Bin Song, MD, PhD — Samsung Medical Center
• Study coordinator: Young Bin Song, MD, PhD
• Email: youngbin.song@gmail.com
• Phone: 82-2-3410-2575

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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.