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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endeavor Resolute stent | Experimental | zotarolimus-eluting stent |
|
| Cypher stent | Active Comparator | sirolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endeavor Resolute stent | Device | zotarolimus-eluting stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic in-segment late loss | 9-month angiographic follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Death (all-cause and cardiac) | at 12 months | |
| myocardial infarction | at 12 months | |
| stent thrombosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | South Korea | |||
| Soonchunhyang University Bucheon Hospital |
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| Cypher stent |
| Device |
sirolimus-eluting stent |
|
| at 12 months |
| target-lesion revascularization | at 12 months |
| target-vessel revascularization | at 12 months |
| Bucheon-si |
| South Korea |
| Soonchunhyang University Cheonan Hospital | Cheonan | South Korea |
| Kangwon University Hospital | Chuncheon | South Korea |
| Daejeon St Mary's Hospital Catholic University | Daejeon | South Korea |
| GangNeung Asan Hospital | Gangneung | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Pusan National University Yangsan Hospital | Pusan | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul Veterans Hospital | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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