Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT07019350

Run by

Samsung Medical Center

People needed

520

Starts

2025-10-22

Expected to finish

2030-12-31

Last updated by the study team

2025-11-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Samsung Medical Center — Seoul, South Korea (enrolling)
• Chonnam National University Hospital — Gwangju, South Korea
• Chosun University Hospital — Gwangju, South Korea

Full record on ClinicalTrials.gov

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