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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT07019350
• Lead Sponsor: Samsung Medical Center

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.

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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-18
• Study Start: 2025-07-31
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Chosun University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of