CompletedNot Applicable

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study

United States2,002 participantsStarted 2013-07

Plain-language summary

Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011. This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China. This study has no primary outcome measure. All observations are of equal weight.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * The patient must be at least 18 years of age at the time of signing the informed consent. * The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF). * Only XIENCE PRIME stent(s) is (are) implanted during the index procedure. Exclusion Criteria: * No other exclusion criteria are specified for this study.

What they're measuring

Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint

Timeframe: ≤ 7 days after index procedure (Hospitalization)

Trial details

NCT IDNCT01894152

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-10-09

Results submitted2017-08-16

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