Coronary Artery DiseaseDCB_DESNCT07442500
Drug Coated Balloon vs. Drug-eluting Stent in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Drug coated balloon and Drug-eluting stent
- Type of treatment
- Medical device
- How many people
- 470,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Feb 2026to 31 Dec 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with de novo coronary artery disease for relatively simple lesions undergoing percutaneous coronary intervention
Who may be able to join
- Patients with coronary artery disease undergoing percutaneous coronary intervention
- Used devices number less than three (relatively simple lesion)
Who cannot join
- Hybrid strategy (DCB and DES use)
- Failed percutaneous coronary intervention
- Previous revascularization procedure before index percutaneous coronary intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul, 06351
Ki Hong Choi, 01088751648
About this study
Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.
- Being tested
- Drug coated balloon, Drug-eluting stent
- Keywords
- Drug coated balloon, Drug-eluting stent, High bleeding risk
- 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.
Drug coated balloonDevice
Patients receiving drug coated balloon angioplasty for de novo coronary artery disease
Drug-eluting stentDevice
Patients receiving drug-eluting stent implantationfor de novo coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Drug coated balloon | Patients receiving drug coated balloon angioplasty Receives: Device: Drug coated balloon | |
| Drug-eluting stent | Patients receiving drug-eluting stent implantation Receives: Device: Drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of MACCE (major adverse cardiac and cerebrovascular events)
all-cause death, myocardial infarction, revascularization, and stroke
Measured: 3 years after index procedure
Secondary outcomes (6)
Rates of Major bleeding
major bleeding requiring transfusion
Measured: 3 years after index procedure
Rates of NACE (net adverse clinical events)
MACCE and any major bleeding requiring transfusion
Measured: 3 years after index procedure
Rates of all-cause death
death from any causes
Measured: 3 years after index procedure
Rates of myocardial infarction
Measured: 3 years after index procedure
Rates of revascularization
repeat revascularization
Measured: 3 years after index procedure
Rates of stroke
Measured: 3 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 470,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
- Investigators
- Ki Hong Choi, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442500
- Sponsor's protocol ID
- DCB_DES
- Acronym
- DCB_DES
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Coated Balloon vs. Drug-eluting Stent in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07442500
- Acronym / sponsor ID
- DCB_DES / DCB_DES
- Keywords
- Drug coated balloon, Drug-eluting stent, High bleeding risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 470,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (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.
Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug coated balloon | – | Device: Drug coated balloonPatients receiving drug coated balloon angioplasty |
| Drug-eluting stent | – | Device: Drug-eluting stentPatients receiving drug-eluting stent implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with de novo coronary artery disease for relatively simple lesions undergoing percutaneous coronary intervention
Key inclusion criteria (2 listed)
- Patients with coronary artery disease undergoing percutaneous coronary intervention
- Used devices number less than three (relatively simple lesion)
Key exclusion criteria (3 listed)
- Hybrid strategy (DCB and DES use)
- Failed percutaneous coronary intervention
- Previous revascularization procedure before index percutaneous coronary intervention
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 |
|---|---|---|
| Drug coated balloonPatients receiving drug coated balloon angioplasty for de novo coronary artery disease | Device | Drug coated balloon |
| Drug-eluting stentPatients receiving drug-eluting stent implantationfor de novo coronary artery disease | Device | Drug-eluting stent |
Primary outcome
Rates of MACCE (major adverse cardiac and cerebrovascular events)
Time frame: 3 years after index procedure
all-cause death, myocardial infarction, revascularization, and stroke
6 secondary outcomes
Rates of Major bleeding
Time frame: 3 years after index procedure
Rates of NACE (net adverse clinical events)
Time frame: 3 years after index procedure
Rates of all-cause death
Time frame: 3 years after index procedure
Rates of myocardial infarction
Time frame: 3 years after index procedure
Rates of revascularization
Time frame: 3 years after index procedure
Rates of stroke
Time frame: 3 years after index procedure
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 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ki Hong Choi, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Samsung Medical Center at 1 site 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of MACCE (major adverse cardiac and cerebrovascular events) (time frame: 3 years after index procedure). 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 2 Mar 2026.