Drug-coated BalloonNCT04619277
Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
An observational study of Drug-coated Balloon, run by Ulsan Medical Center at 1 site in South Korea.
Trial summary
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-coated Balloon
- What is being tested?
- drug-coated balloon
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2011to 31 Dec 2030
- How long will I take part?
- 1 Year
- 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: It is a international multicenter registry study conducted at 4 centers (Queen Elizabeth Hospital II, Peking Shougang Hospital, Ulsan Medical Center, and Ulsan University Hospital) expert in patients with de novo coronary lesion who received DCB treatment.
Who may be able to join
- de novo coronary artery disease
Who cannot join
- unstable hemodynamics at presentation
- life expectancy <1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eun-Seok Shin contact
South Korea1 site, 1 recruiting
- Recruiting
Ulsan Medical Center
Ulsan, 44686
Eun-Seok Shin, sesim1989@gmail.com
About this study
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.
Read the detailed description
There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.
- Conditions
- Drug-coated Balloon
- Being tested
- drug-coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-coated balloonDevice
drug-coated balloon
| Study group | Role | What they receive |
|---|---|---|
| Ulsan Medical Center | Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea Receives: Device: drug-coated balloon | |
| Queen Elizabeth Hospital | Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia Receives: Device: drug-coated balloon | |
| Pecking University Shougand Hospital | Department of Cardiology, Peking University Shougang Hospital, Peking, China Receives: Device: drug-coated balloon | |
| Ulsan University Hospital | Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea Receives: Device: drug-coated balloon | |
| Kangwon National University School of Medicine | Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea Receives: Device: drug-coated balloon | |
| Korea University Guro Hospital | Cardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea Receives: Device: drug-coated balloon | |
| Korea University Ansan Hospital | Department of Cardiology, Korea University Ansan Hospital, Ansan, South Korea Receives: Device: drug-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events at 12 months
Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding [BARC type 3 to 5]) at 12 months.
- Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
- Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
Measured: 12 months
Secondary outcomes (1)
Angiographic and clinical outcomes
- MACE at 12, 24, 36 months
- The single components of the primary endpoint after 12, 24, 36 months. Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding after 12, 24, 36 months.1 (All events will be adjudicated by an independent Critical Events Committee).
- Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, 36 months.
- Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation
- Cost-effectiveness of DCB vs. DES after 12, 24, 36 months.
- All-cause death ⑥ Stroke (ischemic and hemorrhagic)
- Angina severity measured with Seattle Angina Questionnaires at 12, 24 months
- Total procedure time, fluoroscopy time, contrast volume, number of stents used ⑨ DAPT duration ⑩ Periprocedural MI rate ⑪ Sex difference in MACE between DCB vs. DES ⑫ Comparison of MACE between DCB vs. DES in DM patients
Measured: 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start22 Apr 2011
- 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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Drug-coated BalloonStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ulsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-Seok Shin, Ulsan Medical Center
- Investigators
- Soo-Jin Kim, Principal investigator, IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619277
- Sponsor's protocol ID
- USH-20-004
- Other IDs
- USH-20-004
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2020
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kang DO, Kim S, Her AY, Shin ES. Drug-Coated Balloon-Based Strategy for De Novo Coronary Artery Disease Across Complex and High-Risk Indicated Percutaneous Coronary Intervention Risk Categories: A Multicenter Registry Study. Catheter Cardiovasc Interv. 2026 Jul 16. doi: 10.1002/ccd.70756. Online ahead of print.
PubMed 42461258Her AY, Kim S, Kang DO, Sohn CB, Kim YH, Kim B, Shin ES. Drug-Coated Balloon-Based Intervention for De Novo Acute Myocardial Infarction. Yonsei Med J. 2025 Dec;66(12):807-815. doi: 10.3349/ymj.2024.0524.
PubMed 41287492Her AY, Kim TH, Shin ES, Kim S, Kim B, Kim YH, Choi KH, Cho YK, Lee HJ, Song YB, Nam CW, Gwon HC. Drug-Coated Balloon-Based Treatment of Left Main True Bifurcation Lesion. Catheter Cardiovasc Interv. 2025 Apr;105(5):1024-1031. doi: 10.1002/ccd.31416. Epub 2025 Jan 22.
PubMed 39840648Her AY, Shin ES, Kim S, Kim B, Kim TH, Sohn CB, Choi BJ, Park Y, Cho JR, Jeong YH. Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease. Cardiovasc Diabetol. 2023 May 20;22(1):120. doi: 10.1186/s12933-023-01853-0.
PubMed 37210516Shin ES, Jun EJ, Kim S, Kim B, Kim TH, Sohn CB, Her AY, Park Y, Cho JR, Jeong YH, Choi BJ. Clinical Impact of Drug-Coated Balloon-Based Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease. JACC Cardiovasc Interv. 2023 Feb 13;16(3):292-299. doi: 10.1016/j.jcin.2022.10.049. Epub 2023 Jan 4.
PubMed 36609038Jun EJ, Shin ES, Teoh EV, Bhak Y, Yuan SL, Chu CM, Garg S, Liew HB. Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions. Front Cardiovasc Med. 2022 Apr 13;9:821380. doi: 10.3389/fcvm.2022.821380. eCollection 2022.
PubMed 35498010Kun L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Hui L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Sex-Related Outcomes of Successful Drug-Coated Balloon Treatment in De Novo Coronary Artery Disease. Yonsei Med J. 2021 Nov;62(11):981-989. doi: 10.3349/ymj.2021.62.11.981.
PubMed 34672131Hui L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Kun L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes. Yonsei Med J. 2020 Dec;61(12):1004-1012. doi: 10.3349/ymj.2020.61.12.1004.
PubMed 33251774
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
- ClinicalTrials.gov ID
- NCT04619277
- Acronym / sponsor ID
- USH-20-004
- Conditions
- Drug-coated Balloon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ulsan Medical CenterUniversity, hospital or other
- Study start
- 22 Apr 2011 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Nov 2020 (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.
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.
Detailed description
There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Ulsan Medical Center | – | Device: drug-coated balloonDivision of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea |
| Queen Elizabeth Hospital | – | Device: drug-coated balloonCardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia |
| Pecking University Shougand Hospital | – | Device: drug-coated balloonDepartment of Cardiology, Peking University Shougang Hospital, Peking, China |
| Ulsan University Hospital | – | Device: drug-coated balloonDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea |
| Kangwon National University School of Medicine | – | Device: drug-coated balloonDepartment of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea |
| Korea University Guro Hospital | – | Device: drug-coated balloonCardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea |
| Korea University Ansan Hospital | – | Device: drug-coated balloonDepartment of Cardiology, Korea University Ansan Hospital, Ansan, South Korea |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It is a international multicenter registry study conducted at 4 centers (Queen Elizabeth Hospital II, Peking Shougang Hospital, Ulsan Medical Center, and Ulsan University Hospital) expert in patients with de novo coronary lesion who received DCB treatment.
Key inclusion criteria (1 listed)
- de novo coronary artery disease
Key exclusion criteria (2 listed)
- unstable hemodynamics at presentation
- life expectancy <1 year
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 balloondrug-coated balloon | Device | Kangwon National University School of Medicine, Korea University Ansan Hospital, Korea University Guro Hospital, Pecking University Shougand Hospital, Queen Elizabeth Hospital, Ulsan Medical Center, Ulsan University Hospital |
Primary outcome
Major adverse cardiac events at 12 months
Time frame: 12 months
Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding [BARC type 3 to 5]) at 12 months. 1. Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
1 secondary outcome
Angiographic and clinical outcomes
Time frame: 12, 24, 36 months
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 15 Aug 2024.
- Derived from this study: PubMed 42461258Kang DO, Kim S, Her AY, Shin ES. Drug-Coated Balloon-Based Strategy for De Novo Coronary Artery Disease Across Complex and High-Risk Indicated Percutaneous Coronary Intervention Risk Categories: A Multicenter Registry Study. Catheter Cardiovasc Interv. 2026 Jul 16. doi: 10.1002/ccd.70756. Online ahead of print.
- Derived from this study: PubMed 41287492Her AY, Kim S, Kang DO, Sohn CB, Kim YH, Kim B, Shin ES. Drug-Coated Balloon-Based Intervention for De Novo Acute Myocardial Infarction. Yonsei Med J. 2025 Dec;66(12):807-815. doi: 10.3349/ymj.2024.0524.
- Derived from this study: PubMed 39840648Her AY, Kim TH, Shin ES, Kim S, Kim B, Kim YH, Choi KH, Cho YK, Lee HJ, Song YB, Nam CW, Gwon HC. Drug-Coated Balloon-Based Treatment of Left Main True Bifurcation Lesion. Catheter Cardiovasc Interv. 2025 Apr;105(5):1024-1031. doi: 10.1002/ccd.31416. Epub 2025 Jan 22.
- Derived from this study: PubMed 37210516Her AY, Shin ES, Kim S, Kim B, Kim TH, Sohn CB, Choi BJ, Park Y, Cho JR, Jeong YH. Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease. Cardiovasc Diabetol. 2023 May 20;22(1):120. doi: 10.1186/s12933-023-01853-0.
- Derived from this study: PubMed 36609038Shin ES, Jun EJ, Kim S, Kim B, Kim TH, Sohn CB, Her AY, Park Y, Cho JR, Jeong YH, Choi BJ. Clinical Impact of Drug-Coated Balloon-Based Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease. JACC Cardiovasc Interv. 2023 Feb 13;16(3):292-299. doi: 10.1016/j.jcin.2022.10.049. Epub 2023 Jan 4.
- Derived from this study: PubMed 35498010Jun EJ, Shin ES, Teoh EV, Bhak Y, Yuan SL, Chu CM, Garg S, Liew HB. Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions. Front Cardiovasc Med. 2022 Apr 13;9:821380. doi: 10.3389/fcvm.2022.821380. eCollection 2022.
- Derived from this study: PubMed 34672131Kun L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Hui L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Sex-Related Outcomes of Successful Drug-Coated Balloon Treatment in De Novo Coronary Artery Disease. Yonsei Med J. 2021 Nov;62(11):981-989. doi: 10.3349/ymj.2021.62.11.981.
- Derived from this study: PubMed 33251774Hui L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Kun L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes. Yonsei Med J. 2020 Dec;61(12):1004-1012. doi: 10.3349/ymj.2020.61.12.1004.
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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.
Eun-Seok Shin contact
Soo-Jin Kim principal investigator
IRB
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 Drug-coated Balloon, run by Ulsan 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 1 inclusion and 2 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 15 Aug 2024. 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?
Contact Eun-Seok Shin (sesim1989@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 events at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619277, which also lists 8 linked publications.
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 15 Aug 2024.