CompletedNot Applicable

PROMUS PREMIER™ China Post-Approval Study

China2,059 participantsStarted 2018-01-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)

Timeframe: 12-month follow up

Trial details

NCT IDNCT03273023

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-12-28

View on ClinicalTrials.gov More Coronary Artery Disease trials