Coronary Artery DiseaseDCB-HBRNCT05221931
Drug-Coated Balloon in Patients With High Bleeding Risk
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Samsung Medical Center at 17 sites in South Korea.
Trial summary
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial. The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion in patients with high bleeding risk (HBR). 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?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,359 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 29 Jul 2022to Dec 2028
- 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
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm
- Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated < 3 years (8) Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis (11) Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons
Who cannot join
- Patients unable to provide consent
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- Patients with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting
- Patients who have non-cardiac co-morbid conditions with life expectancy <2 year
- Patients who may result in protocol non-compliance (site investigator's medical judgment)
- Patients with cardiogenic shock or cardiac arrest
Show all 9Show fewer
- Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- Patients with severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Korea University Ansan Hospital
Ansan
Chungbuk National University
Cheongju-si
Keimyung University Dongsan Hospital
Daegu
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung
Chonnam National University Hospital
Gwangju
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Inha University Hospital
Incheon
Gyeongsang National University Hospital
Jinju
Seoul National University Bundang Hospital
Seongnam-si
Ewha Womans University College of Medicine
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Kuro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Boramae Medical Center
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk (DCB-HBR Trial)
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial.
The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion in patients with high bleeding risk (HBR).
Read the detailed description
Second-generation DES is the standard of care for patients with coronary artery disease who are deemed eligible for percutaneous coronary intervention (PCI). Despite many advantages, DES inevitably accompany disadvantages such as the occurrence of late stent thrombosis and the need for maintaining dual antiplatelet (DAPT) for certain period due to permanent vascular implant, which lead to both increased ischemic and bleeding events.
As an alternative to DES, drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT), its use has been established in in-stent restenosis of bare-metal stents (BMS) and DES. Furthermore, recently published RCT demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels with reference vessel size<3.0mm. However, studies exploring the feasibility of DCB in de-novo coronary artery stenosis beyond small vessels are limited. Furthermore, there is scarce data comparing DCB with DES in patients with de-novo coronary artery stenosis and high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In previous BASKET-SMALL 2 trial, DCB showed noninferiority to DES in patients with de-novo coronary artery stenosis and small vessel disease. However, this trial was conducted in non-HBR patients, and the number of participated patients was insufficient. In another RCT, DEBUT trial exclusively enrolled patients with HBR and de-novo coronary artery stenosis. Although the DEBUT trial showed superiority of DCB angioplasty over implantation of BMS to treat de-novo coronary artery stenosis in patients with HBR, the results could not be applicable in contemporary practice because BMS has been no longer in clinical use. Recently, multiple RCTs have proved short-term DAPT (1-3 months) has comparable efficacy to longer term DAPT in HBR patients using latest second-generation DES.
On this background, the current trial aims to compare clinical outcomes between DCB and DES to treat de-novo coronary artery stenosis in patients with HBR receiving guideline-directed short-term DAPT.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention
- Keywords
- Percutaneous Coronary Intervention, De-Novo Coronary Lesion, Drug-Coated Balloon, High Bleeding Risk, 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.
Percutaneous coronary interventionProcedure or surgery
1:1 randomization to DES (Ultimaster Tansei) or DCB (Agent [Boston Scientific, USA], Prevail [Medtronic, USA], or SeQuent Please, SeQuent Please NEO [B-Braun, Germany])
| Study group | Role | What they receive |
|---|---|---|
| DES group | Active comparator | Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography.
In DES group, latest second-generation DES will be used (Ultimaster Tansei) during the index procedure Receives: Procedure: Percutaneous coronary intervention |
| DCB group | Experimental | Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography.
In DCB group, Agent (Boston Scientific, USA), Prevail (Medtronic, USA), or SeQuent Please, SeQuent Please NEO (B-Braun, Germany) will be used during the index procedure. Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure (TVF)
a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)
Measured: 2 years from last patient enrollment
Secondary outcomes (39)
BARC type 2, 3 or 5 bleeding (Major secondary endpoint)
BARC type 2, 3 or 5 bleeding
Measured: 2 years from last patient enrollment
Cardiovascular death
Cardiovascular death
Measured: 2 years from last patient enrollment
All-cause death
All-cause death
Measured: 2 years from last patient enrollment
Target-vessel MI
Target-vessel MI
Measured: 2 years from last patient enrollment
Non-target vessel related MI
Non-target vessel related MI
Measured: 2 years from last patient enrollment
Non-fatal MI
Non-fatal MI
Measured: 2 years from last patient enrollment
Clinically indicated target-lesion revascularization (TLR)
Clinically indicated target-lesion revascularization (TLR)
Measured: 2 years from last patient enrollment
Clinically indicated TVR
Clinically indicated TVR
Measured: 2 years from last patient enrollment
Non-target vessel revascularization
Non-target vessel revascularization
Measured: 2 years from last patient enrollment
Any revascularization
Any revascularization
Measured: 2 years from last patient enrollment
Vessel or stent thrombosis
definite by Academic Research Consortium (ARC) definition
Measured: 2 years from last patient enrollment
Cardiovascular death or target-vessel MI
Cardiovascular death or target-vessel MI
Measured: 2 years from last patient enrollment
Target vessel failure without procedure-related MI
a composite of cardiovascular death, target-vessel myocardial infarction (MI) without procedure-related MI, and clinically indicated target-vessel revascularization (TVR)
Measured: 2 years from last patient enrollment
Target lesion failure (TLF)
a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR
Measured: 2 years from last patient enrollment
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
Measured: 2 years from last patient enrollment
All-cause death, non-fatal MI, or any revascularization
All-cause death, non-fatal MI, or any revascularization
Measured: 2 years from last patient enrollment
Bleeding according to BARC definition
Bleeding according to BARC definition
Measured: 2 years from last patient enrollment
Bleeding according to TIMI definition
Bleeding according to TIMI definition
Measured: 2 years from last patient enrollment
Cerebrovascular accident (CVA)
Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack (TIA)
Measured: 2 years from last patient enrollment
Target vessel failure (TVF) at Extended Follow-up
a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR) at Extended Follow-up
Measured: 4 years from last patient enrollment
BARC type 2, 3 or 5 bleeding (Major secondary endpoint) at Extended Follow-up
BARC type 2, 3 or 5 bleeding at Extended Follow-up
Measured: 4 years from last patient enrollment
Cardiovascular death at Extended Follow-up
Cardiovascular death at Extended Follow-up
Measured: 4 years from last patient enrollment
All-cause death at Extended Follow-up
All-cause death at Extended Follow-up
Measured: 4 years from last patient enrollment
Target-vessel MI at Extended Follow-up
Target-vessel MI at Extended Follow-up
Measured: 4 years from last patient enrollment
Non-target vessel related MI at Extended Follow-up
Non-target vessel related MI at Extended Follow-up
Measured: 4 years from last patient enrollment
Non-fatal MI at Extended Follow-up
Non-fatal MI at Extended Follow-up
Measured: 4 years from last patient enrollment
Clinically indicated target-lesion revascularization (TLR) at Extended Follow-up
Clinically indicated target-lesion revascularization (TLR) at Extended Follow-up
Measured: 4 years from last patient enrollment
Clinically indicated TVR at Extended Follow-up
Clinically indicated TVR at Extended Follow-up
Measured: 4 years from last patient enrollment
Non-target vessel revascularization at Extended Follow-up
Non-target vessel revascularization at Extended Follow-up
Measured: 4 years from last patient enrollment
Any revascularization at Extended Follow-up
Any revascularization at Extended Follow-up
Measured: 4 years from last patient enrollment
Vessel or stent thrombosis at Extended Follow-up
definite ㅍessel or stent thrombosis at Extended Follow-up by Academic Research Consortium (ARC) definition
Measured: 4 years from last patient enrollment
Target vessel failure without procedure-related MI at Extended Follow-up
a composite of cardiovascular death, target-vessel myocardial infarction (MI) without procedure-related MI, and clinically indicated target-vessel revascularization (TVR)
Measured: 4 years from last patient enrollment
Cardiovascular death or target-vessel MI at Extended Follow-up
Cardiovascular death or target-vessel MI at Extended Follow-up
Measured: 4 years from last patient enrollment
Target lesion failure (TLF) at Extended Follow-up
Target lesion failure (TLF) at Extended Follow-up
Measured: 4 years from last patient enrollment
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis at Extended Follow-up
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis at Extended Follow-up
Measured: 4 years from last patient enrollment
All-cause death, non-fatal MI, or any revascularization at Extended Follow-up
All-cause death, non-fatal MI, or any revascularization at Extended Follow-up
Measured: 4 years from last patient enrollment
Bleeding according to BARC definition at Extended Follow-up
Bleeding according to BARC definition at Extended Follow-up
Measured: 4 years from last patient enrollment
Bleeding according to TIMI definition at Extended Follow-up
Bleeding according to TIMI definition at Extended Follow-up
Measured: 4 years from last patient enrollment
Cerebrovascular accident (CVA) at Extended Follow-up
Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack (TIA)
Measured: 4 years from 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 posted3 Feb 2022
- Study start29 Jul 2022
- Primary completionNov 2027 (estimated)
- Study completionDec 2028 (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
- Prospective, multi-center, open-label, randomized controlled, noninferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, Korea University Ansan Hospital, Chonnam National University Hospital, Chung-Ang University Gwangmyeong Hospital, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gyeongsang National University Hospital, Uijeongbu St. Mary Hospital, Keimyung University Dongsan Medical Center, Inha University Hospital, Chungbuk National University, Wonju Severance Christian Hospital, SMG-SNU Boramae Medical Center, Kangbuk Samsung Hospital, Sungkyunkwan University, Ewha Womans University, Korea University Guro Hospital
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
- Investigators
- Joo Myung Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221931
- Sponsor's protocol ID
- DCBHBR2021-12-111-001
- Acronym
- DCB-HBR
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. 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 De-Novo Coronary Lesions in Patients With High Bleeding Risk (DCB-HBR Trial)
- ClinicalTrials.gov ID
- NCT05221931
- Acronym / sponsor ID
- DCB-HBR / DCBHBR2021-12-111-001
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, De-Novo Coronary Lesion, Drug-Coated Balloon, High Bleeding Risk, Prognosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,359 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, Korea University Ansan Hospital, Chonnam National University Hospital, Chung-Ang University Gwangmyeong Hospital, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gyeongsang National University Hospital, Uijeongbu St. Mary Hospital, Keimyung University Dongsan Medical Center, Inha University Hospital, Chungbuk National University, Wonju Severance Christian Hospital, SMG-SNU Boramae Medical Center, Kangbuk Samsung Hospital, Sungkyunkwan University, Ewha Womans University, Korea University Guro Hospital
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Feb 2022 (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.
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial.
The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion in patients with high bleeding risk (HBR).
Detailed description
Second-generation DES is the standard of care for patients with coronary artery disease who are deemed eligible for percutaneous coronary intervention (PCI). Despite many advantages, DES inevitably accompany disadvantages such as the occurrence of late stent thrombosis and the need for maintaining dual antiplatelet (DAPT) for certain period due to permanent vascular implant, which lead to both increased ischemic and bleeding events.
As an alternative to DES, drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT), its use has been established in in-stent restenosis of bare-metal stents (BMS) and DES. Furthermore, recently published RCT demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels with reference vessel size<3.0mm. However, studies exploring the feasibility of DCB in de-novo coronary artery stenosis beyond small vessels are limited. Furthermore, there is scarce data comparing DCB with DES in patients with de-novo coronary artery stenosis and high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In previous BASKET-SMALL 2 trial, DCB showed noninferiority to DES in patients with de-novo coronary artery stenosis and small vessel disease. However, this trial was conducted in non-HBR patients, and the number of participated patients was insufficient. In another RCT, DEBUT trial exclusively enrolled patients with HBR and de-novo coronary artery stenosis. Although the DEBUT trial showed superiority of DCB angioplasty over implantation of BMS to treat de-novo coronary artery stenosis in patients with HBR, the results could not be applicable in contemporary practice because BMS has been no longer in clinical use. Recently, multiple RCTs have proved short-term DAPT (1-3 months) has comparable efficacy to longer term DAPT in HBR patients using latest second-generation DES.
On this background, the current trial aims to compare clinical outcomes between DCB and DES to treat de-novo coronary artery stenosis in patients with HBR receiving guideline-directed short-term DAPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-center, open-label, randomized controlled, noninferiority trial
| Arm | Type | Receives |
|---|---|---|
| DES group | Active comparator | Procedure: Percutaneous coronary interventionPatients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography. In DES group, latest second-generation DES will be used (Ultimaster Tansei) during the index procedure |
| DCB group | Experimental | Procedure: Percutaneous coronary interventionPatients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography. In DCB group, Agent (Boston Scientific, USA), Prevail (Medtronic, USA), or SeQuent Please, SeQuent Please NEO (B-Braun, Germany) will be used during the index procedure. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be at least 19 years of age
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm
- Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated < 3 years (8) Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis (11) Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons
Key exclusion criteria (9 listed)
- Patients unable to provide consent
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- Patients with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting
- Patients who have non-cardiac co-morbid conditions with life expectancy <2 year
- Patients who may result in protocol non-compliance (site investigator's medical judgment)
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 |
|---|---|---|
| Percutaneous coronary intervention1:1 randomization to DES (Ultimaster Tansei) or DCB (Agent [Boston Scientific, USA], Prevail [Medtronic, USA], or SeQuent Please, SeQuent Please NEO [B-Braun, Germany]) | Procedure or surgery | DCB group, DES group |
Primary outcome
Target vessel failure (TVF)
Time frame: 2 years from last patient enrollment
a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)
39 secondary outcomes
BARC type 2, 3 or 5 bleeding (Major secondary endpoint)
Time frame: 2 years from last patient enrollment
Cardiovascular death
Time frame: 2 years from last patient enrollment
All-cause death
Time frame: 2 years from last patient enrollment
Target-vessel MI
Time frame: 2 years from last patient enrollment
Non-target vessel related MI
Time frame: 2 years from last patient enrollment
Non-fatal MI
Time frame: 2 years from last patient enrollment
Clinically indicated target-lesion revascularization (TLR)
Time frame: 2 years from last patient enrollment
Clinically indicated TVR
Time frame: 2 years from last patient enrollment
Non-target vessel revascularization
Time frame: 2 years from last patient enrollment
Any revascularization
Time frame: 2 years from last patient enrollment
Vessel or stent thrombosis
Time frame: 2 years from last patient enrollment
Cardiovascular death or target-vessel MI
Time frame: 2 years from last patient enrollment
Target vessel failure without procedure-related MI
Time frame: 2 years from last patient enrollment
Target lesion failure (TLF)
Time frame: 2 years from last patient enrollment
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
Time frame: 2 years from last patient enrollment
All-cause death, non-fatal MI, or any revascularization
Time frame: 2 years from last patient enrollment
Bleeding according to BARC definition
Time frame: 2 years from last patient enrollment
Bleeding according to TIMI definition
Time frame: 2 years from last patient enrollment
Cerebrovascular accident (CVA)
Time frame: 2 years from last patient enrollment
Target vessel failure (TVF) at Extended Follow-up
Time frame: 4 years from last patient enrollment
BARC type 2, 3 or 5 bleeding (Major secondary endpoint) at Extended Follow-up
Time frame: 4 years from last patient enrollment
Cardiovascular death at Extended Follow-up
Time frame: 4 years from last patient enrollment
All-cause death at Extended Follow-up
Time frame: 4 years from last patient enrollment
Target-vessel MI at Extended Follow-up
Time frame: 4 years from last patient enrollment
Non-target vessel related MI at Extended Follow-up
Time frame: 4 years from last patient enrollment
Non-fatal MI at Extended Follow-up
Time frame: 4 years from last patient enrollment
Clinically indicated target-lesion revascularization (TLR) at Extended Follow-up
Time frame: 4 years from last patient enrollment
Clinically indicated TVR at Extended Follow-up
Time frame: 4 years from last patient enrollment
Non-target vessel revascularization at Extended Follow-up
Time frame: 4 years from last patient enrollment
Any revascularization at Extended Follow-up
Time frame: 4 years from last patient enrollment
Vessel or stent thrombosis at Extended Follow-up
Time frame: 4 years from last patient enrollment
Target vessel failure without procedure-related MI at Extended Follow-up
Time frame: 4 years from last patient enrollment
Cardiovascular death or target-vessel MI at Extended Follow-up
Time frame: 4 years from last patient enrollment
Target lesion failure (TLF) at Extended Follow-up
Time frame: 4 years from last patient enrollment
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis at Extended Follow-up
Time frame: 4 years from last patient enrollment
All-cause death, non-fatal MI, or any revascularization at Extended Follow-up
Time frame: 4 years from last patient enrollment
Bleeding according to BARC definition at Extended Follow-up
Time frame: 4 years from last patient enrollment
Bleeding according to TIMI definition at Extended Follow-up
Time frame: 4 years from last patient enrollment
Cerebrovascular accident (CVA) at Extended Follow-up
Time frame: 4 years from 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 12 Feb 2026.
- Individual participant dataSharing planned: Yes. After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
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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. This study is not recruiting at the moment.
Joo Myung Lee, MD, PhD principal investigator
Samsung Medical Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Samsung Medical Center at 17 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (TVF) (time frame: 2 years from 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 12 Feb 2026.