Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: drug-coated balloon.
- Who it may be relevant to
- Registry conditions: Drug-coated Balloon. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device drug-coated balloon
drug-coated balloon
Primary outcome measures
- Major adverse cardiac events at 12 months [Time frame: 12 months]
Secondary outcome measures (1)
- Angiographic and clinical outcomes [Time frame: 12, 24, 36 months]
Eligibility criteria
Inclusion criteria
\- de novo coronary artery disease
Exclusion criteria
- unstable hemodynamics at presentation
- life expectancy <1 year
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Ulsan Medical Center — Ulsan
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. PMID 42461258
- Her 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. PMID 41287492
- Her 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. PMID 39840648
- Her 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. PMID 37210516
- Shin 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. PMID 36609038
- Jun 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. PMID 35498010
- Kun 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. PMID 34672131
- Hui 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. PMID 33251774
Identifiers
NCT: NCT04619277 · USH-20-004 · USH-20-004