NCT07019350Recruiting
Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon
Drug-Coated Balloon Versus Drug-eluting Stent for Treatment of Clinically Relevant Side Branch in Complex Coronary Bifurcation Lesion
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 22 Oct 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT07019350
What you commit to
- Study type: Interventional
- Planned participants: 520
- From 22 Oct 2025 to the primary completion date, 31 Dec 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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)
Lab values
- Severe left ventricular systolic dysfunction (ejection fraction \<30%)
Other
- Intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, or heparin.
- Unwillingness or inability to comply with the procedures described in this protocol.
Who the study is looking for
- 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.
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Not yet recruiting |
| Chosun University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Not yet recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.