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Active, Not Recruiting

NCT Number: NCT02593994

IRIS-Onyx Cohort in the IRIS-DES Registry

The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, Republic of Korea, 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 19 and more
  • Intervention with Onyx Drug Eluting Stent
  • Agreed with written informed consent form

Exclusion criteria

  • Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time
  • Life expectancy of 1year and under
  • Cardiac shock

Treatment and study plan

Onyx Drug Eluting Stent group

Device

Primary outcomes

  1. Stent thrombosis

    Time frame: 1 year

    As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis

Secondary outcomes

  1. All death

    Time frame: 5 year

  2. Cardiac death

    Time frame: 5 year

  3. Myocardial infarction

    Time frame: 5 year

  4. Composite event of death or myocardial infarction

    Time frame: 5 year

  5. Composite event of cardiac death or myocardial infarction

    Time frame: 5 year

  6. Composite event rate

    Time frame: 5 year

    death, myocardial infarction, target vessel revascularization

  7. Target Vessel revascularization

    Time frame: 5 year

  8. Target Lesion revascularization

    Time frame: 5 year

  9. Stent thrombosis

    Time frame: 5 year

  10. Stroke

    Time frame: 5 year

  11. Procedural success

    Time frame: 3 day

    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

  • CardioVascular Research Foundation, Korea
  • Medtronic Korea Co., Ltd.

Registry information

Official study title

Evaluation of Effectiveness and Safety of Resolute Onyx™ and Onyx Frontier™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Acronym: IRIS-Onyx

Important dates

Study start
2015
Primary completion
2027
Study completion
2031
First posted
Nov 2, 2015
Registry last updated
Jun 24, 2026

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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