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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent and/or Ultimaster Nagomi stent in the "real-world" daily practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary artery stenosis | Patients with coronary artery disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultimasterâ„¢ Tanseiâ„¢ stent and/or Ultimaster Nagomiâ„¢ stent | Device | Patients receiving Ultimasterâ„¢ Tanseiâ„¢ stent and/or Ultimaster Nagomiâ„¢ stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) | the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post-procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of all death | 5 years | |
| The event rate of cardiac death | 5 years | |
| The event rate of myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Ultimasterâ„¢ Tanseiâ„¢ stent and/or Ultimaster Nagomiâ„¢ stents.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-hee Ham, RN | Contact | 82230104728 | cvcrc5@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangwon National Univ. Hospital | Withdrawn | Chuncheon | South Korea | |||
| Daegu Catholic University Medical Center |
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| 5 years |
| The composite event rate of death or myocardial infarction | 5 years |
| the composite event rate of cardiac death or myocardial infarction | 5 years |
| The event rate of target-vessel revascularization | 5 years |
| The event rate of target-lesion revascularization | 5 years |
| The event rate of stent thrombosis | According to Academic Research Consortium(ARC) criteria | 5 years |
| The event rate of stroke | 5 years |
| The event rate of procedural success | Defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization. | 3 days |
| The event rate of bleeding complications | TIMI(Thrombolysis in Myocardial Infarction), BARC(Bleeding Academic Research Consortium) criteria | 5 years |
| Recruiting |
| Daegu |
| South Korea |
|
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
|
| The Catholic University of Korea, Daejeon ST. Mary's Hospital | Recruiting | Daejeon | South Korea |
|
| Gangneung Asan Hospital | Recruiting | Gangneung | South Korea |
|
| Kwangju Christian Hospital | Recruiting | Kwangju | South Korea |
|
| Pusan National University Hospital | Recruiting | Pusan | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | South Korea |
|
| Kangdong Sacred Heart Hospital | Recruiting | Seoul | South Korea |
|
| The Catholic Univ. of Korea Eunpyeong St. Mary's hospital | Withdrawn | Seoul | South Korea |
| St.Carollo Hospital | Recruiting | Suncheon | South Korea |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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