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At sponsor's discretion : The purpose of study is no longer maintained
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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultimaster stent | Experimental |
| |
| Xience alpine stent | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultimaster stent | Device | Percutaneous coronary intervention with Ultimaster stent for long lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late luminal loss | 13-month |
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangwon National Univ. Hospital | Chuncheon | South Korea | ||||
| Asan Medical Center |
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| Xience alpine stent | Device | Percutaneous coronary intervention with Xience alpine stent for long lesion |
|
| 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 | 1 year |
| In-stent late loss | In-stent late loss at 13-month angiographic follow-up | 13-month |
| In-stent and in-segment restenosis | In-stent and in-segment restenosis at 13-month angiographic follow-up | 13-month |
| Angiographic pattern of restenosis | Angiographic pattern of restenosis at 13 -month angiographic follow-up | 13-month |
| Volume of intimal hyperplasia | Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study) | 13-month |
| Incidence of late stent malapposition | Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study) | 13-month |
| Procedural success | 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. | 5 days |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| 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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