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IRIS-PREMIER REGISTRY

Evaluation of Effectiveness and Safety of Promus PREMIER in Routine Clinical Practice; A Multicenter, Phase-IV, Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02060968
Acronym
IRIS-PREMIER
Enrollment
2006
Registered
2014-02-12
Start date
2014-08-31
Completion date
2021-06-30
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia

Keywords

Promus PREMIER, Routine Clinical Practice

Brief summary

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

Interventions

DEVICEPromus PREMIER

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Boston Scientific Korea Co. Ltd
CollaboratorINDUSTRY
Seung-Jung Park
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite event rate1yearDeath, non fatal myocardial infarction, Target Vessel Revascularization

Secondary

MeasureTime frameDescription
Composite event of cardiac death or myocardial infarction5year
Target Vessel revascularization5year
Target lesion revascularization5year
Stent thrombosis by an Academic Research Consortium (ARC) criteria5year
Composite event of death or myocardial infarction5year
All death5year
Cardiac death5year
Myocardial infarction5year
Procedural success3daydefined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days.
Stroke5year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026