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To place two different everolimus-eluting stents (EES), a bioabsorbable polymer EES (Synergy®) and a permanent-type polymer EES (Xience®), randomly to the ST-elevation acute myocardial infarction (AMI) and to observe and compare the early and chronic vascular responses using the frequency domain optical coherence tomography (FD-OCT). The primary endpoint is the 2-week strut coverage rate by FD-OCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The SYNERGY stent | Active Comparator |
| |
| Xience | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Device | Coronary Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-weeks strut coverage rate by FD-OCT | In this clinical study, the 2-week covered strut rate by FD-OCT should be considered the primary endpoint, and the non-inferiority of Synergy® to the present standard treatment, Xience®, established in the control group in the treatment of STEMI, should be demonstrated. | 2-weeks |
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Inclusion Criteria:
Exclusion Criteria:
If the following exclusion criteria are satisfied, the patient should not be enrolled in this study even after acquisition of patient's consent:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihiro Morino, MD | Iwate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iwate Medical University Hospital | Morioka | 020-8505 | Japan |
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| 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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