PROMUS PREMIER™ China Post-Approval Study
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03273023
- Lead Sponsor
- Boston Scientific Corporation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2059
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) 12-month follow up 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China