Clinical trial NCT07019350: Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon
Official title: Drug-Coated Balloon Versus Drug-eluting Stent for Treatment of Clinically Relevant Side Branch in Complex Coronary Bifurcation Lesion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Complex Coronary Bifurcation
Upfront 2-stenting
Upfront Drug-coated Balloon
Side Branch
Prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 520
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multi-center, open-label, randomized controlled, superiority trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 1 year after last patient enrollment
Secondary outcomes:
measure: All-cause death
timeFrame: 1 year after last patient enrollment
measure: Cardiac death
timeFrame: 1 year after last patient enrollment
measure: Any MI (myocardial infarction)
timeFrame: 1 year after last patient enrollment
measure: Spontaneous MI (myocardial infarction)
timeFrame: 1 year after last patient enrollment
measure: Procedure-related MI (myocardial infarction)
timeFrame: 1 year after last patient enrollment
measure: Stent thrombosis
timeFrame: 1 year after last patient enrollment
measure: Unplanned revascularization (clinically-driven)
timeFrame: 1 year after last patient enrollment
measure: Target-vessel revascularization (clinically-driven)
timeFrame: 1 year after last patient enrollment
measure: Cerebrovascular accidents (ischemic or hemorrhagic)
timeFrame: 1 year after last patient enrollment
measure: Bleeding (BARC 2, 3, or 5)
timeFrame: 1 year after last patient enrollment
measure: Seattle Angina Questionnaire (SAQ) (angina severity)
timeFrame: 1 year after last patient enrollment
measure: Procedure-related complications during index procedure
timeFrame: 1 year after last patient enrollment
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Bin Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: