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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
| Medtronic | INDUSTRY |
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This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) 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 IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cypher | Active Comparator | Sirolimus-eluting stent |
|
| Endeavor Resolute | Active Comparator | Zotarolimus-eluting Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cypher | Device | Sirolimus-eluting stent |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late luminal loss | 9 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All Death | 1 year | |
| 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 |
|---|---|---|---|---|---|---|
| Stcarollo Hospital | Suncheon | Cheon-nam | South Korea | |||
| Konyang University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23048051 | Derived | Ahn JM, Park DW, Kim YH, Song H, Cho YR, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Han S, Lee SY, Lee BK, Cho JH, Yang TH, Lee NH, Yang JY, Park JS, Shin WY, Kim MH, Bae JH, Kim MK, Yoon J, Park SJ. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES IV trial. Circ Cardiovasc Interv. 2012 Oct;5(5):633-40. doi: 10.1161/CIRCINTERVENTIONS.111.965673. Epub 2012 Oct 9. |
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| Endeavor Resolute | Device | Zotarolimus-eluting Stent |
|
|
| 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) | 12 months |
| 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 (normal hospitalization is from 3 -4 days.) | at 3 days in average |
| All death | one month |
| All death | 9 months |
| 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 |
| Daejeon |
| Chungcheongnam-do |
| South Korea |
| Wonju Christian Hospital | Wŏnju | Gangwon-do | South Korea |
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | Gyeonggi-do | South Korea |
| Inje University Ilsan Paik Hospital | Ilsan | Gyeonggi-do | South Korea |
| Yeungnam University Medical Center | Daegu | Kyung-book | South Korea |
| Busan Paik Hospital | Busan | South Korea |
| Dong-A University Medical Center | Busan | South Korea |
| Soonchunhyang University Cheonan Hospital | Cheonan | South Korea |
| Gangwon National University Hospital | Chuncheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Kyung Hee University Medical Hospital | Seoul | 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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