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To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promus Element | Active Comparator | Everolimus-eluting stent |
|
| Nobori | Active Comparator | Biolimus-eluting stent with biodegradable polymer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promus Element, Boston Scientific Corporation | Device | Everolimus-eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis | 1 year after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis | 2 years after index procedure | |
| Death (all-cause and cardiac) | 1 to 2 years after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jea Tahk, MD, PhD | Department of Cardiology, Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea | ||||
| Sejong Hospital |
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| Nobori, Terumo Corporation (Japan) | Device | Biolimus-eluting stent with biodegradable polymer |
|
|
| Myocardial infarction (Q wave and non-Q wave) | 1 to 2 years after index procedure |
| Target vessel revascularization (ischemia- and clinically-driven) | 1 to 2 years after index procedure |
| Target lesion revascularization (ischemia- and clinically-driven) | 1 to 2 years after index procedure |
| Stent thrombosis | 1 to 2 years after index procedure |
| In-stent and in-segment late loss at 1 year angiographic follow-up | 1 year after index procedure |
| In-stent and in-segment restenosis at 1 year angiographic follow-up | 1 year after index procedure |
| Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up | 1 year after index procedure |
| The incidence of Procedural success | index procedure (day 0) |
| The number of participants with death and myocardial infarction | 1 to 2 years after index procedure |
| Bucheon-si |
| South Korea |
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | South Korea |
| Soon Chun Hyang University Hospital Cheonan | Cheonan | South Korea |
| Kangwon National University Hospital | Chuncheon | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Hospital | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Konyang University Hospital | Daejeon | South Korea |
| Gangneung Asan Hospital | Gangneung | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Inje University ilsan Paik Hospital | Ilsan | South Korea |
| Gachon University Gil Hospital | Incheon | South Korea |
| Cheju Halla General Hospital | Jeju City | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Hallym University Hankang Sacred Heart Hospital | Seoul | South Korea |
| Hallym University Kangdong Sacred Heart Hospital | Seoul | South Korea |
| Kyunghee University Medical Center | Seoul | South Korea |
| The Catholic University of Korea Seoul ST. Mary's Hospital | Seoul | South Korea |
| Yonsei University Gangnam Severance Hospital | Seoul | South Korea |
| St. Carollo Hospital | Suncheon | South Korea |
| Ajou University Medical Center | Suwon | South Korea |
| Catholic University ST. Vincent's Hospital | Suwon | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| Yonsei University Wonju College of Medicine Wonju Christion Hospital | Wŏnju | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 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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