Optimal side-branch stenting strategy for complex coronary bifurcation using drug-coated balloons
Drug-Coated Balloon Versus Drug-eluting Stent for Treatment of Clinically Relevant Side Branch in Complex Coronary Bifurcation Lesion
This study tests whether starting with two stents or using a drug-coated balloon (DCB)-based hybrid approach works better for adults having PCI for complex coronary bifurcation lesions with an important side branch.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 3 sites (Gwangju and 2 other locations) |
| Trial ID | NCT07019350 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥19 years) with acute or chronic coronary syndrome planned for PCI who have de novo true coronary bifurcation lesions with a clinically relevant side branch (Medina 1,1,1; 1,0,1; 0,1,1) with SB lesion length ≥10 mm and meeting the protocol's stenosis/size criteria, and who can give informed consent are ideal candidates.
Not a fit: Patients who are hemodynamically unstable, who do not have a true or clinically significant side-branch lesion, who have very small side branches that do not meet size criteria, or who are not PCI candidates are unlikely to benefit from this trial's treatments.
Why it matters
Potential benefit: If successful, the approach could reduce the need for repeat procedures and lower stent-related complications for patients with complex bifurcation lesions.
How similar studies have performed: Previous trials have shown mixed results—some favor upfront two-stent strategies for very complex bifurcations, while recent studies of DCB use at side branches have produced promising but not yet definitive results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gwangju and 2 other locations
- Chonnam National University Hospital — Gwangju, South Korea (Not_yet_recruiting)
- Chosun University Hospital — Gwangju, South Korea (Not_yet_recruiting)
- Samsung Medical Center — Seoul, South Korea (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
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.