Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT07019350

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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