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OpenTrials
Completed

NCT Number: NCT02060968

IRIS-PREMIER REGISTRY

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Promus PREMIER

Device

Primary outcomes

  1. Composite event rate

    Time frame: 1year

    Death, non fatal myocardial infarction, Target Vessel Revascularization

Secondary outcomes

  1. All death

    Time frame: 5year

  2. Cardiac death

    Time frame: 5year

  3. Myocardial infarction

    Time frame: 5year

  4. Composite event of death or myocardial infarction

    Time frame: 5year

  5. Composite event of cardiac death or myocardial infarction

    Time frame: 5year

  6. Target Vessel revascularization

    Time frame: 5year

  7. Target lesion revascularization

    Time frame: 5year

  8. Stent thrombosis by an Academic Research Consortium (ARC) criteria

    Time frame: 5year

  9. Stroke

    Time frame: 5year

  10. Procedural success

    Time frame: 3day

    defined 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.

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • Boston Scientific Korea Co. Ltd
  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS-PREMIER

Important dates

Study start
2014
Primary completion
2017
Study completion
2021
First posted
Feb 12, 2014
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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