NCT03273023CompletedNot Applicable
Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China
Boston Scientific Corporation1 site in 1 country2,059 target enrollmentStarted: January 11, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,059
- Locations
- 1
- Primary Endpoint
- 12-month Major Adverse Cardiac Event (MACE) Rate
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an "all comers" study.
Outcomes
Primary Outcomes
12-month Major Adverse Cardiac Event (MACE) Rate
Time Frame: 12 months
12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR).
Secondary Outcomes
- 12-month Cardiac Death(12 months)
- 12-month Myocardial Infarction(12 months)
- 12-month TVR(12 months)
Investigators
Study Sites (1)
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