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

Drug-Coated Balloon Versus Drug-eluting Stent for Treatment of Clinically Relevant Side Branch in Complex Coronary Bifurcation Lesion

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Upfront DCB-based hybrid strategy; Other: Upfront 2-stenting strategy

Detailed Description

Among complex coronary artery lesions, percutaneous coronary intervention (PCI) for true bifurcation lesions has been challenging to perform and associated with a higher risk of mortality, unplanned repeat revascularization or stent thrombosis.15-17 Although current guidelines recommend 1-stenting with provisional side branch approach as an initial treatment strategy for the bifurcation lesions based on previous trials,11,12,18-22 there are studies that demonstrate better or similar outcomes with the upfront 2-stenting strategy.3,4,21,23 Of note, these trials that have favored upfront 2-stenting strategy have shown a tendency for better efficacy of 2-stenting as the severity of bifurcation lesions increases.3,4,21,23 Considering that the discrepancy among study results could be attributable to the complexity of true bifurcation lesions, it can be argued that 1-stenting with provisional SB approach by conventional balloon dilatation shows limitations in dealing with severely complex true bifurcation lesions.

During provisional stenting, unplanned side branch stenting is associated with worse clinical outcomes.24 In addition, SB failure occurred more frequently than main vessel failure in both 1-stenting and 2-stenting group.25 Considering these results, there have been some studies trying to demonstrate the effect of drug-coated balloon (DCB) angioplasty at side branch during the PCI for bifurcation lesions.5,26 In the most recent trial, DCB angioplasty yielded better results compared to conventional simple balloon dilatation.5 Thus, for true bifurcation lesions, upfront DCB-based hybrid strategy could serve as a good alternative treatment strategy that improves clinical outcomes for patients with complex coronary bifurcation lesion with clinically relevant side branch.

On this background, this trial sought to compare the clinical outcomes between upfront DCB-based hybrid strategy and upfront 2-stenting strategy in patients with complex coronary bifurcation with clinically relevant side branch.

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joo Myung Lee, MD, MPH, PhD; Phone Number: 82-2-3410-2575; Email: drone80@hanmail.net
• Study Contact Backup: Name: Young Bin Song, MD, PhD; Phone Number: 82-2-3410-2575; Email: youngbin.song@gmail.com

Study Locations

• South Korea
  • Gwangju, South Korea
    • Not yet recruiting
    • Chonnam National University Hospital
    • Contact: Seung Hun Lee, MD, PhD; Phone Number: 82-10-6413-7449; Email: lsh8602@naver.com
  • Gwangju, South Korea
    • Not yet recruiting
    • Chosun university hospital
    • Contact: Hyun Kuk Kim, MD, PhD
  • Seoul, South Korea
    • Recruiting
    • Samsung Medical Center
    • Contact: Joo Myung Lee, MD, MPH, PhD; Phone Number: 82-2-3410-2575; Email: drone80@hanmal.net
    • Sub-Investigator: Joo Myung Lee, MD, MPH, PhD
    • Sub-Investigator: Jeong Hoon Yang, MD, PhD
    • Contact: Young Bin Song, MD, PhD; Phone Number: 82-2-3410-2575; Email: youngbin.song@gmail.com
    • Principal Investigator: Young Bin Song, MD, PhD
    • Sub-Investigator: Ki-Hong Choi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upfront DCB-based hybrid strategy; In upfront DCB-based hybrid strategy group, stepwise provisional strategy with side branch DCB angioplasty will be performed according to the follow standardized procedural steps. In this group, provisional stenting strategy will be performed in accordance with the European Bifurcation Club (EBC) consensus. Bail-out stenting will be performed using operator's preferred technique (e.g. T, TAP, culotte) when there will be one of the following after hybrid strategy: <TIMI 3 flow in the side branch, severe (>90%) ostial pinching, or flow-limiting dissection.	Other: Upfront DCB-based hybrid strategy; In upfront DCB-based hybrid strategy group, stepwise provisional strategy with side branch DCB angioplasty will be performed according to the follow standardized procedural steps. In this group, provisional stenting strategy will be performed in accordance with the European Bifurcation Club (EBC) consensus. Bail-out stenting will be performed using operator's preferred technique (e.g. T, TAP, culotte) when there will be one of the following after hybrid strategy: 90%) ostial pinching, or flow-limiting dissection.
Active Comparator: Upfront 2-stenting strategy; In upfront 2-stenting strategy group, systematic planned 2-stenting will be performed according to EBC recommendations. The stent technique will be at the discretion of the operator but could be one of culotte, DK-culotte, mini-crush, DK-crush, T or TAP.	Other: Upfront 2-stenting strategy; In upfront 2-stenting strategy group, systematic planned 2-stenting will be performed according to EBC recommendations. The stent technique will be at the discretion of the operator but could be one of culotte, DK-culotte, mini-crush, DK-crush, T or TAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Event (MACE)	MACE (a composite of death, MI, clinically-driven target-vessel revascularization), according to the Academic Research Consortium (ARC) II-consensus.	1 year after last patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause death	1 year after last patient enrollment
Cardiac death	Cardiac death	1 year after last patient enrollment
Any MI (myocardial infarction)	Any MI, defined by Fourth Universal definition of M	1 year after last patient enrollment
Spontaneous MI (myocardial infarction)	Spontaneous MI (myocardial infarction), defined by Fourth Universal definition of MI	1 year after last patient enrollment
Procedure-related MI (myocardial infarction)	Procedure-related MI (myocardial infarction), defined by ARC II definition	1 year after last patient enrollment
Stent thrombosis	Stent thrombosis, defined by ARC II definition	1 year after last patient enrollment
Unplanned revascularization (clinically-driven)	Unplanned revascularization (clinically-driven)	1 year after last patient enrollment
Target-vessel revascularization (clinically-driven)	Target-vessel revascularization (clinically-driven)	1 year after last patient enrollment
Cerebrovascular accidents (ischemic or hemorrhagic)	Cerebrovascular accidents (ischemic or hemorrhagic)	1 year after last patient enrollment
Bleeding (BARC 2, 3, or 5)	Bleeding (BARC 2, 3, or 5)	1 year after last patient enrollment
Seattle Angina Questionnaire (SAQ) (angina severity)	Seattle Angina Questionnaire (SAQ) (angina severity)	1 year after last patient enrollment
Procedure-related complications during index procedure	Procedure-related complications during index procedure	1 year after last patient enrollment

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Young Bin Song, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 5, 2025
• First Posted (Actual): June 13, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Prognosis; Complex Coronary Bifurcation; Upfront 2-stenting; Upfront Drug-coated Balloon; Side Branch
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: SMC-SMART-STRATEGY-DCB-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,
• IPD Sharing Time Frame: After completion of primary trial report
• IPD Sharing Access Criteria: Upon reasonable requests, executive committee members will have discussion about sharing the individual participant data (IPD).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No