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Due to current BVS safety issue
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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABSORB BVS | Experimental |
| |
| XIENCE EES | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus-eluting bioresorbable vascular (Absorb) scaffold | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | 5 years | |
| Target-vessel myocardial infarction | 5 years | |
| Ischemia-driven target-lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
This is not a publicly funded trial.
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| everolimus-eluting cobalt-chromium (Xience) stent |
| Device |
|
|
| 5 years |
| All-cause mortality | 5 years |
| event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction | 5 years |
| Any revascularization | Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven | 5 years |
| Target-vessel failure | death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization | 5 years |
| Stent thrombosis | 5 years |
| event rate of device success or procedural success | Device success defined as angiographic evidence of <30% final residual stenosis of the target lesion. Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death. | 5 years |
| Patient-reported angina status measured by Seattle angina questionnaire | 5 years |
| 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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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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