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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus versus everolimus-eluting stent implantation for long coronary lesions.
Following angiography, patients with significant diameter stenosis >50% and lesion length (> 25mm) requiring single or multiple long-stent placement (total stent length >28mm) by visual estimation and eligible for LONG-DES III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting stent by the stratified randomization method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cypher | Active Comparator | Sirolimus-eluting stent |
|
| Xience V | Active Comparator | Everolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cypher | Device | Sirolimus-eluting stent implantation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late luminal loss | 9 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All Death | one month | |
| Cardiac death | 1 year | |
| Myocardial infarction (MI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sam Anyang Hospital | Anyang | South Korea | ||||
| Soonchunhyang University Bucheon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22017935 | Derived | Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Seung KB, Yang TH, Lee SG, Lee JH, Seong IW, Cheong SS, Lee BK, Lee NH, Lee SW, Lee SW, Lee K, Kim HS, Jeon DS, Kim MK, Nah DY, Tahk SJ, Park SJ. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. JACC Cardiovasc Interv. 2011 Oct;4(10):1096-103. doi: 10.1016/j.jcin.2011.05.024. |
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| Xience V | Device | Everolimus-eluting Stent implantation |
|
|
| 1 year |
| Composite of death or MI | 1 year |
| Composite of cardiac death or MI | 1 year |
| Target vessel revascularization (ischemia-driven and clinically-driven) | 1 year |
| Target lesion revascularization (ischemia-driven and clinically-driven) | 1 year |
| Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) | 1 year |
| Stent thrombosis (ARC criteria) | 1 year |
| In-stent late loss at 9 month angiographic follow-up | at 9 month angiographic follow-up |
| In-stent and in-segment restenosis at 9 month angiographic follow-up | at 9 month angiographic follow-up |
| Angiographic pattern of restenosis at 9 month angiographic follow-up | at 9 month angiographic follow-up |
| Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) | at 9 month angiographic follow-up |
| Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) | at 9 month angiographic follow-up |
| Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay. | At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days. | 3 days in average |
| All Death | 9 months |
| All Death | one year |
| Cardiac death | one month |
| Cardiac death | 9 months |
| Myocardial infarction (MI) | one month |
| Myocardial infarction (MI) | 9 months |
| Composite of death or MI | one month |
| Composite of death or MI | 9 months |
| Composite of cardiac death or MI | one month |
| Composite of cardiac death or MI | 9 months |
| Target vessel revascularization (ischemia-driven and clinically-driven) | one month |
| Target vessel revascularization (ischemia-driven and clinically-driven) | 9 months |
| Target lesion revascularization (ischemia-driven and clinically-driven) | one month |
| Target lesion revascularization (ischemia-driven and clinically-driven) | 9 months |
| Stent thrombosis (ARC criteria) | one month |
| Stent thrombosis (ARC criteria) | 9 months |
| Bucheon-si |
| South Korea |
| Busan Paik Hospital | Busan | South Korea |
| St.Mary's Catholic Medical Center | Busan | South Korea |
| Soonchunhyang University Cheonan Hospital | Cheonan | South Korea |
| St.Mary's Catholic Medical Center | Cheongju-si | South Korea |
| Gangwon National University Hospital | Chuncheon | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Asan Medical Center | Gangneung | South Korea |
| Gwangju Christian Hospital | Gwangju | South Korea |
| Dongguk University Hospital | Gyongju | South Korea |
| St.Mary's Catholic Medical Center | Inchon | South Korea |
| Jeju Hanla Hospital | Jeju City | South Korea |
| Gyeongsang Uniservity Hospital | Jinju | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Hangang Sacred Heart Hospital | Seoul | South Korea |
| Seoul Veterans Hospital | Seoul | South Korea |
| St.Mary's Catholic Medical Center | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Ulsan University Hospital | Ulsan | 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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