Coronary Artery DiseaseSMART-DCBNCT07019350
Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon
A study testing Upfront DCB-based hybrid strategy and Upfront 2-stenting strategy in people with Coronary Artery Disease, run by Samsung Medical Center at 3 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Upfront DCB-based hybrid strategy and Upfront 2-stenting strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 22 Oct 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Not yet recruiting
Chonnam National University Hospital
Gwangju
Seung Hun Lee, MD, PhD, 82-10-6413-7449, lsh8602@naver.com
- Not yet recruiting
Chosun University Hospital
Gwangju
Hyun Kuk Kim, MD, PhD
- Recruiting
Samsung Medical Center
Seoul
Young Bin Song, MD, PhD, 82-2-3410-2575, youngbin.song@gmail.com
Joo Myung Lee, MD, MPH, PhD, 82-2-3410-2575, drone80@hanmal.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Upfront DCB-based hybrid strategy, Upfront 2-stenting strategy
- Keywords
- Complex Coronary Bifurcation, Upfront 2-stenting, Upfront Drug-coated Balloon, Side Branch, Prognosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upfront DCB-based hybrid strategyOther
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 2-stenting strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Upfront 2-stenting strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after last patient enrollment
Secondary outcomes (12)
All-cause death
All-cause death
Measured: 1 year after last patient enrollment
Cardiac death
Cardiac death
Measured: 1 year after last patient enrollment
Any MI (myocardial infarction)
Any MI, defined by Fourth Universal definition of M
Measured: 1 year after last patient enrollment
Spontaneous MI (myocardial infarction)
Spontaneous MI (myocardial infarction), defined by Fourth Universal definition of MI
Measured: 1 year after last patient enrollment
Procedure-related MI (myocardial infarction)
Procedure-related MI (myocardial infarction), defined by ARC II definition
Measured: 1 year after last patient enrollment
Stent thrombosis
Stent thrombosis, defined by ARC II definition
Measured: 1 year after last patient enrollment
Unplanned revascularization (clinically-driven)
Unplanned revascularization (clinically-driven)
Measured: 1 year after last patient enrollment
Target-vessel revascularization (clinically-driven)
Target-vessel revascularization (clinically-driven)
Measured: 1 year after last patient enrollment
Cerebrovascular accidents (ischemic or hemorrhagic)
Cerebrovascular accidents (ischemic or hemorrhagic)
Measured: 1 year after last patient enrollment
Bleeding (BARC 2, 3, or 5)
Bleeding (BARC 2, 3, or 5)
Measured: 1 year after last patient enrollment
Seattle Angina Questionnaire (SAQ) (angina severity)
Seattle Angina Questionnaire (SAQ) (angina severity)
Measured: 1 year after last patient enrollment
Procedure-related complications during index procedure
Procedure-related complications during index procedure
Measured: 1 year after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start22 Oct 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multi-center, open-label, randomized controlled, superiority trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Bin Song, Samsung Medical Center
- Investigators
- Young Bin Song, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019350
- Sponsor's protocol ID
- SMC-SMART-STRATEGY-DCB-2025
- Acronym
- SMART-DCB
- Status last verified
- Nov 2025
- First submitted
- 5 Jun 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloon Versus Drug-eluting Stent for Treatment of Clinically Relevant Side Branch in Complex Coronary Bifurcation Lesion
- ClinicalTrials.gov ID
- NCT07019350
- Acronym / sponsor ID
- SMART-DCB / SMC-SMART-STRATEGY-DCB-2025
- Conditions
- Coronary Artery Disease
- Keywords
- Complex Coronary Bifurcation, Upfront 2-stenting, Upfront Drug-coated Balloon, Side Branch, Prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, multi-center, open-label, randomized controlled, superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Upfront DCB-based hybrid strategy | Experimental | Other: Upfront DCB-based hybrid strategyIn 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 2-stenting strategy | Active comparator | Other: Upfront 2-stenting strategyIn 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upfront DCB-based hybrid strategyIn 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 strategyIn 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 |
Primary outcome
Major Adverse Cardiac Event (MACE)
Time frame: 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.
12 secondary outcomes
All-cause death
Time frame: 1 year after last patient enrollment
Cardiac death
Time frame: 1 year after last patient enrollment
Any MI (myocardial infarction)
Time frame: 1 year after last patient enrollment
Spontaneous MI (myocardial infarction)
Time frame: 1 year after last patient enrollment
Procedure-related MI (myocardial infarction)
Time frame: 1 year after last patient enrollment
Stent thrombosis
Time frame: 1 year after last patient enrollment
Unplanned revascularization (clinically-driven)
Time frame: 1 year after last patient enrollment
Target-vessel revascularization (clinically-driven)
Time frame: 1 year after last patient enrollment
Cerebrovascular accidents (ischemic or hemorrhagic)
Time frame: 1 year after last patient enrollment
Bleeding (BARC 2, 3, or 5)
Time frame: 1 year after last patient enrollment
Seattle Angina Questionnaire (SAQ) (angina severity)
Time frame: 1 year after last patient enrollment
Procedure-related complications during index procedure
Time frame: 1 year after last patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes. After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Young Bin Song, MD, PhD principal investigator
Samsung Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upfront DCB-based hybrid strategy and Upfront 2-stenting strategy in people with Coronary Artery Disease, run by Samsung Medical Center at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Bin Song, MD, PhD (82-2-3410-2575, youngbin.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Event (MACE) (time frame: 1 year after last patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.