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

Completed

• Conditions: Cardiovascular Disease; Coronary Artery Disease; Coronary Heart Disease; Angioplasty; Myocardial Infarction; Coronary Restenosis; Stent Thrombosis; Vascular Disease
• Interventions: Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

• Registration Number: NCT01894152
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Results First Submitted: 2017-08-16
• Results First Submitted QC: 2018-12-26
• Results First Posted: 2019-04-01
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2002

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)	Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint	≤ 7 days after index procedure (Hospitalization)	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.

Trial Locations

Locations (1)

Abbott Vascular; 🇺🇸 Santa Clara, California, United States