This trial is active, not recruiting.

Conditions angioplasty, transluminal, percutaneous coronary, coronary artery disease
Treatment orsiro™ drug eluting stent group
Sponsor Seung-Jung Park
Collaborator CardioVascular Research Foundation, Korea
Start date July 2014
End date September 2017
Trial size 1007 participants
Trial identifier NCT02039739, AMCCV2014-02


The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
orsiro™ drug eluting stent group

Primary Outcomes

Composite event rate
time frame: 1YEAR

Secondary Outcomes

time frame: 5YEAR
time frame: 5YEAR
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
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 Orsiro™ Drug Eluting Stent - Agreed with written informed consent form Exclusion Criteria: - Intervention with Orsiro™ drug 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 Orsiro™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Asan Medical Center.