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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| St Vincent's Hospital | OTHER |
| Uijeongbu St. Mary Hospital | OTHER |
| Gachon University Gil Medical Center |
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This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid strategy | The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion. |
| |
| DES only | The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-coated balloon | Device | For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used. |
| Measure | Description | Time Frame |
|---|---|---|
| The reclassification rate of the treatment strategy | The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease. | At the time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy | Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy | At the time of procedure |
| Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy |
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Inclusion Criteria:
Age 19 or older
Multivessel coronary artery disease patients requiring coronary intervention
Capable of understanding the risks and benefits of participating in the study and providing informed consent
Exclusion Criteria:
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Patients with multivessel coronary artery disease who undergo coronary intervention
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bon-Kwon Koo, MD, PhD | Contact | +82-2-2072-2062 | bkkoo@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Bon-Kwon Koo, MD, PhD | +82-2-2072-2062 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bon-Kwon Koo | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| OTHER |
| Gangnam Severance Hospital | OTHER |
| Kyunghee University Medical Center | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Inje University Ilsan Paik Hospital | OTHER |
| Daegu Catholic University Medical Center | OTHER |
| Sejong General Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Soonchunhyang University Hospital | OTHER |
| Yeungnam University Hospital | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Ulsan University Hospital | OTHER |
| Ewha Womans University Mokdong Hospital | OTHER |
| Inje University | OTHER |
| Chonnam National University Hospital | OTHER |
| Chung-Ang University Gwangmyeong Hospital | OTHER |
| Chung-Ang University Hospital | OTHER |
| Ulsan Medical Center | OTHER |
| Hanyang University Seoul Hospital | OTHER |
| Jeju National University Hospital | OTHER |
| KangWon National University Hospital | OTHER |
| Uijeongbu Eulji University Hospital | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Severance Hospital | OTHER |
| Chosun University Hospital | OTHER |
| Kyungpook National University Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| Kyung Hee University Hospital at Gangdong | OTHER |
| Ajou University School of Medicine | OTHER |
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| drug-eluting stent | Device | When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines. |
|
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy |
| At the time of procedure |
| Cardiovascular death | Cardiovascular death | 1 year |
| All-cause death | All-cause death | 1 year |
| Non-fatal myocardial infarction (MI) | Non-fatal myocardial infarction (MI) | 1 year |
| Target vessel MI excluding periprocedural MI | Target vessel MI excluding periprocedural MI | 1 year |
| Target vessel MI including periprocedural MI | Target vessel MI including periprocedural MI | 1 year |
| Clinically indicated target lesion revascularization | Clinically indicated target lesion revascularization | 1 year |
| Clinically indicated target vessel revascularization | Clinically indicated target vessel revascularization | 1 year |
| Any revascularization | Any revascularization | 1 year |
| Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition | Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition | 1 year |
| Cardiovascular death or target vessel MI | Cardiovascular death or target vessel MI | 1 year |
| All-cause death or non-fatal MI | All-cause death or non-fatal MI | 1 year |
| Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization | Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization | 1 year |
| Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization | Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization | 1 year |
| Cardiovascular death, target vessel MI, or vessel or stent thrombosis | Cardiovascular death, target vessel MI, or vessel or stent thrombosis | 1 year |
| All-cause death, non-fatal MI, or clinically indicated target vessel revascularization | All-cause death, non-fatal MI, or clinically indicated target vessel revascularization | 1 year |
| Major bleeding events (BARC type 2, 3, or 5) | Major bleeding events (BARC type 2, 3, or 5) | 1 year |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |