Post-Approval Study of PROMUS Element™ in China

PROMUS Element™ China Post-Approval Study

The purpose of this study is to compile real-world clinical outcomes data for the PROMUS Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) in routine clinical practice in China.

Everolimus-eluting stents have been studied extensively in ongoing clinical studies. The safety and effectiveness of the everolimus drug and polymer combination have been studied extensively in the SPIRIT Clinical Trial Program. The PROMUS Element stent is currently being studied in the PLATINUM Clinical Trial Program. The PROMUS Element stent is also being evaluated in PROMUS Element Plus US post-approval studies and the ongoing Platinum China study. This study is designed to provide post-market surveillance information on the PROMUS Element™ and PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) after it has been approved by SFDA (State of Food and Drug Administration) in China. The study will evaluate clinical outcomes for subjects receiving the PROMUS Element and PROMUS Element plus stents over 5 years in a real world setting according to post approval requirements from SFDA.

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 Element stent OR Subject who is clinically indicated and was implanted with at least one PROMUS Element stent
• Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion Criteria:

• Exclusion criteria is not required in the PROMUS Element China Post-Approval study which is an "all comers" study.