IRIS-Onyx Cohort in the IRIS-DES Registry (IRIS-Onyx)

June 23, 2026 updated by: Seung-Jung Park

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Anyang, South Korea
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, South Korea
        • Soon Chun Hyang University Hospital Bucheon
      • Cheonan, South Korea
        • Soon Chun Hyang University Hospital Cheonan
      • Chuncheon, South Korea
        • Gangwon National Univ. Hospital
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • Daegu, South Korea
        • Daegu Catholic University Medical Center
      • Daejeon, South Korea
        • Chungnam National University Hospital
      • Daejeon, South Korea
        • The Catholic University of Korea, Daejeon ST. Mary's Hospital
      • Gangneung, South Korea
        • Gangneung Asan Hospital
      • Gwangju, South Korea
        • Chonnam National University Hospital
      • Ilsan, South Korea
        • Inje University Ilsan Paik Hospital
      • Jeonju, South Korea
        • Presbyterian Medical Center
      • Kwangju, South Korea
        • Kwangju Christian Hospital
      • Pusan, South Korea
        • Inje University Pusan Paik Hospital
      • Pusan, South Korea
        • Pusan National University Hospital
      • Pusan, South Korea
        • Dong-A Medical Center
      • Seongnam, South Korea
        • Bundang CHA Hospital
      • Seoul, South Korea
        • Kangbuk Samsung Hospital
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Korea University Guro Hospital
      • Seoul, South Korea
        • Gangnam Severance Hospital
      • Seoul, South Korea
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Seoul, South Korea
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, South Korea
        • The Catholic University of Korea St. Paul's Hospital
      • Seoul, South Korea
        • Kangdong Sacred Heart Hospital
      • Suncheon, South Korea
        • St.Carollo Hospital
      • Ulsan, South Korea
        • Ulsan University Hospital
      • Wŏnju, South Korea
        • Wonju Severance Christian Hospital
      • Yangsan, South Korea
        • Pusan National University Yangsan Hospital
    • Republic of Korea
      • Seoul, Republic of Korea, South Korea
        • The Catholic University of Korea, Yeouido ST. Mary's Hospital
    • Songpa-gu
      • Seoul, Songpa-gu, South Korea, 138-736
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with Onyx Drug Eluting Stent

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Onyx Drug Eluting Stent
Device: Onyx Drug Eluting Stent group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stent thrombosis
Time Frame: 1 year
As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 5 year
5 year
Myocardial infarction
Time Frame: 5 year
5 year
Stent thrombosis
Time Frame: 5 year
5 year
Stroke
Time Frame: 5 year
5 year
All death
Time Frame: 5 year
5 year
Composite event of death or myocardial infarction
Time Frame: 5 year
5 year
Composite event of cardiac death or myocardial infarction
Time Frame: 5 year
5 year
Composite event rate
Time Frame: 5 year
death, myocardial infarction, target vessel revascularization
5 year
Target Vessel revascularization
Time Frame: 5 year
5 year
Target Lesion revascularization
Time Frame: 5 year
5 year
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.
3 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CardioVascular Research Foundation, Korea
Medtronic Korea Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMCCV2015-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not a publicly funded trial.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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