Status:
COMPLETED
PROMUS PREMIER™ China Post-Approval Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 en...
Eligibility Criteria
Inclusion
- 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
- Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an "all comers" study.
Key Trial Info
Start Date :
January 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 3 2025
Estimated Enrollment :
2059 Patients enrolled
Trial Details
Trial ID
NCT03273023
Start Date
January 11 2018
End Date
October 3 2025
Last Update
December 29 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China