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

Abbott Medical Devices2,002 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,002

Conditions

Angioplasty Cardiovascular Disease Coronary Artery Disease Coronary Heart Disease Coronary Restenosis Myocardial Infarction Stent Thrombosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.

Time frame: ≤ 7 days after index procedure (Hospitalization)