Overview

This trial is active, not recruiting.

Conditions coronary artery disease, myocardial ischemia, coronary disease, heart diseases
Treatment promus premier
Sponsor Seung-Jung Park
Collaborator CardioVascular Research Foundation, Korea
Start date June 2014
End date June 2017
Trial size 2006 participants
Trial identifier NCT02060968, AMCCV2014-03

Summary

The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in Routine Clinical Practice

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Promus PREMIER
promus premier

Primary Outcomes

Measure
Composite event rate
time frame: 1year

Secondary Outcomes

Measure
All death
time frame: 5year
Cardiac death
time frame: 5year
Myocardial infarction
time frame: 5year
Composite event of death or myocardial infarction
time frame: 5year
Composite event of cardiac death or myocardial infarction
time frame: 5year
Target Vessel revascularization
time frame: 5year
Target lesion revascularization
time frame: 5year
Stent thrombosis by an Academic Research Consortium (ARC) criteria
time frame: 5year
procedural success
time frame: 3day

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Age 20 and more - Intervention with Promus PREMIER everolimus eluting coronary stent - Agreed with written informed consent form Exclusion Criteria: - Intervention with Promus PREMIER everolimus eluting coronary stent and other drug eluting stent at the same time - Life expectancy of 1year and under - Cardiac shock

Additional Information

Official title Evaluation of Effectiveness and Safety of Promus PREMIER in Routine Clinical Practice; A Multicenter, Phase-IV, Prospective Observational Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Asan Medical Center.