N/A
Completed N=2,002
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Source: ClinicalTrials.gov NCT01894152 ↗Enrolled (actual)
2,002
Serious AEs
55.2%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint — 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint |
114 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01894152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.