Post-Approval Study of PROMUS Element™ in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2016 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No