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The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DM arms | Active Comparator | comparison of two different stents(Xience prime and Resolute integrity) |
|
| Small vessel arms | Active Comparator | comparison of two different stents(Xience prime and Resolute integrity) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary intervention using drug eluting stent | Procedure | 1. Intracoronary stenting
|
| Measure | Description | Time Frame |
|---|---|---|
| in-segment late lumen loss (mm)at 12month | 12month |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiac events(MACE) at 12month | 1) Occurrence of major adverse cardiac events (MACE) during 12 months
| 12month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lae young Jung, fellow | Contact | 82-63-250-2204 | youngjoin@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Devision of cardiology, Chonbuk national university hospital | Recruiting | Jeonju | Chon-buk | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| MACE at 24month | 2) Occurrence of major adverse cardiac events (MACE) during 24 months
| 24month |
| procedure success rate | Procedure success rate proportion of investigational stent deployed successfully without chage to other stent | 1 day (after procedure) |