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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The objectives of this study are
Secondary endpoints are
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onyx | The patients who received PCI with Resolute Onyx stent(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Onyx | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis, acute | according to Academic Research Consortium (ARC) definition | within 24 hours after index PCI |
| Stent thrombosis, subacute | according to ARC definition |
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Inclusion Criteria:
Exclusion Criteria:
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All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyxâ„¢ stent(s)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo-soo Kim, MD, PhD | Contact | +82-2-2072-2226 | hyosoo@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyo-soo Kim, MD, PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gospel Hospital | Recruiting | Busan | South Korea |
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| from 24 hours to 30 days after index PCI |
| Stent thrombosis, late | according to ARC definition | from 30 days to 1 year after index PCI |
| Stent thrombosis, very-late | according to ARC definition | 1 year ~ up to 3 years |
| Target vessel failure | Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR) | 12 months |
| Composite rate of cardiac death and myocardial infarction | as title | 12 months, 3 years |
| Composite rate of all-cause death and any myocardial infarction | as title | 12 months, 3 years |
| Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization | as title | 12 months, 3 years |
| Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy | we will estimate this outcome with relevant questionnaire | 12 months, 3 years |
| Clinical device and procedural success rate | device success : residual stenosis <30%, final thrombolysis in myocardial infarction (TIMI) flow grade III procedural success : device success + no adverse events immediate after the procedure | intraoperative ( index PCI) |
| Soon Chun Hyang University Hospital Cheonan | Recruiting | Cheonan | South Korea |
|
| Myongji Hospital | Recruiting | Goyang | South Korea |
|
| Gwangju Christian Hospital | Recruiting | Gwangju | South Korea |
|
| Kwangju Veterans Hospital | Recruiting | Gwangju | South Korea |
|
| Chungbuk National University Hospital | Recruiting | Jeonju | South Korea |
|
| Presbyterian Medical Center | Recruiting | Jeonju | South Korea |
|
| Gyeongsang National University Hospital | Recruiting | Jinju | South Korea |
|
| Pusan National University Hospital | Recruiting | Pusan | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
|
| Gangbuk Samsung Hospital | Recruiting | Seoul | South Korea |
|
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Soonchunhyang University Hospital | Recruiting | Seoul | South Korea |
|
| St. Vincent's Hospital | Recruiting | Suwon | South Korea |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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