Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEPromus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Promus PREMIERTM Stent System
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 18 years of age * Subject understands and provides written informed consent * Subject who is clinically indicated and will have an attempt of at least one Promus PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least one Promus PREMIERTM Stent * Subject is willing to comply with all protocol-required follow-up evaluation
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month Major Adverse Cardiac Event (MACE) Rate | 12 months | 12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-month Cardiac Death | 12 months | Participants occurred cardiac death event in 12 months |
| 12-month Myocardial Infarction | 12 months | Participants occurred myocardial infarction event in 12 months |
| 12-month TVR | 12 months | Participants occurred TVR event in 12 months |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORBo Yu, Dr.
The Second Affiliated Hospital of Harbin Medical University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2059 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 2059 participants |
| Sex: Female, Male Female | 588 Participants |
| Sex: Female, Male Male | 1471 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 30 / 2,059 |
| other Total, other adverse events | 58 / 2,059 |
| serious Total, serious adverse events | 48 / 2,059 |
Outcome results
None listed