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

NCT07019350 | Recruiting DMC

• 1 other identifier: SMC-SMART-STRATEGY-DCB-2025
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 3

Brief Summary

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

Coronary Artery Disease

Keywords

Complex Coronary Bifurcation; Upfront 2-stenting; Upfront Drug-coated Balloon; Side Branch; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• All-cause death

  1 year after last patient enrollment

• Cardiac death

  1 year after last patient enrollment

• Any MI (myocardial infarction)

  1 year after last patient enrollment

• Spontaneous MI (myocardial infarction)

  1 year after last patient enrollment

• Procedure-related MI (myocardial infarction)

  1 year after last patient enrollment

Study Arms (2)

Upfront DCB-based hybrid strategy

EXPERIMENTAL

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

Upfront 2-stenting strategy

ACTIVE COMPARATOR

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

Interventions

Upfront DCB-based hybrid strategy OTHER

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.

Upfront DCB-based hybrid strategy

Upfront 2-stenting strategy OTHER

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.

Upfront 2-stenting strategy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (3)

Chonnam National University Hospital

Gwangju, South Korea

NOT YET RECRUITING

Chosun University Hospital

Gwangju, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Young Bin Song, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Bin Song, MD, PhD

CONTACT

82-2-3410-2575; youngbin.song@gmail.com

Joo Myung Lee, MD, MPH, PhD

CONTACT

82-2-3410-2575; drone80@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, multi-center, open-label, randomized controlled, superiority trial.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After completion of primary trial report
• Access Criteria: Upon reasonable requests, executive committee members will have discussion about sharing the individual participant data (IPD).

Locations

KR (3)