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To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.
Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or clinic visit
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System | Device | Promus PREMIERTM Stent System |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) | The primary endpoint is the 12-month major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) | 12-month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who are candidates for coronary artery stenting, signed the informed consent form and eligible to receive a Promus PREMIERTM Stent System will be evaluated for enrollment in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, Dr. | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2026 | |
| Reset | May 22, 2026 | |
| Release | Jun 4, 2026 | |
| Unrelease | Jun 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2026 | May 22, 2026 | |||
| Jun 4, 2026 | Jun 15, 2026 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Jun 16, 2026 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |