Actively Recruiting
Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon
Led by Samsung Medical Center · Updated on 2025-11-24
520
Participants Needed
3
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, multi-center, open-label, randomized controlled, superiority trial. The aim of the study is to compare clinical outcomes between upfront 2-stenting strategy versus upfront drug-coated balloon (DCB)-based hybrid strategy in patients with complex coronary bifurcation with clinically relevant side branch lesions.
CONDITIONS
Official Title
Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Patients with acute or chronic coronary syndrome planned for percutaneous coronary intervention (PCI)
- Patients with de novo complex coronary bifurcation lesions involving a clinically relevant side branch defined as true bifurcation lesion (Medina 1,1,1 / 1,0,1 / 0,1,1) with side branch lesion length 10 mm or more
- Lesions meeting at least one of the following: left main bifurcation with side branch stenosis 70% or more by visual estimation; or non-left main bifurcation with side branch reference vessel diameter 2.75 mm or larger and stenosis 90% or more by visual estimation
- Ability to understand the risks, benefits, and treatment alternatives and provide written informed consent
You will not qualify if you...
- Hemodynamically unstable condition including systolic blood pressure less than 90 mmHg despite vasopressors, ventricular arrhythmias, or cardiogenic shock
- Known true anaphylaxis to contrast medium
- Significant congenital, severe valvular, or cardiomyopathic conditions explaining cardiac symptoms
- Severe left ventricular systolic dysfunction with ejection fraction less than 30%
- Intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, or heparin
- Non-cardiac conditions with life expectancy less than 1 year or that may prevent protocol compliance
- Unwillingness or inability to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Chonnam National University Hospital
Gwangju, South Korea
Not Yet Recruiting
2
Chosun University Hospital
Gwangju, South Korea
Not Yet Recruiting
3
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
Y
Young Bin Song, MD, PhD
CONTACT
J
Joo Myung Lee, MD, MPH, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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