PROMUS PREMIER™ China Post-Approval Study

Boston Scientific

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT03273023

S2384

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,059 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.