XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
NCT ID: NCT01894152 Phase: Status: COMPLETED Enrollment: 2002 Completion: 2019-10-09
Conditions
Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease, Coronary Restenosis, Myocardial Infarction, Stent Thrombosis, Vascular Disease
Interventions
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
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.
Primary Outcome
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint