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| ID | Type | Description | Link |
|---|---|---|---|
| USH-20-004 | Registry Identifier | Ulsan Medical Center |
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This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulsan Medical Center | Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea |
| |
| Queen Elizabeth Hospital | Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia |
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| Pecking University Shougand Hospital | Department of Cardiology, Peking University Shougang Hospital, Peking, China |
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| Ulsan University Hospital | Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea |
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| Kangwon National University School of Medicine | Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea |
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| Korea University Guro Hospital |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-coated balloon | Device | drug-coated balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic and clinical outcomes |
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Inclusion Criteria:
- de novo coronary artery disease
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun-Seok Shin | Contact | sesim1989@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Soo-Jin Kim | IRB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan Medical Center | Recruiting | Ulsan | 44686 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41287492 | Derived | 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. | |
| 39840648 | Derived | 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. |
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Cardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea
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| Korea University Ansan Hospital | Department of Cardiology, Korea University Ansan Hospital, Ansan, South Korea |
|
| 12, 24, 36 months |
| 37210516 | Derived | 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. |
| 36609038 | Derived | 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. |
| 35498010 | Derived | 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. |
| 34672131 | Derived | 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. |
| 33251774 | Derived | 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. |