Coronary Artery DiseaseIRIS-OnyxNCT02593994
IRIS-Onyx Cohort in the IRIS-DES Registry
An observational study of Coronary Artery Disease and Arterial Occlusive Diseases, run by Seung-Jung Park at 31 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases
- What is being tested?
- Onyx Drug Eluting Stent group
- Type of treatment
- Medical device
- How many people
- 4,500 participants
- Where
- 31 sitesSouth Korea
- Study dates
- Oct 2015to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Onyx Drug Eluting Stent
Who may be able to join
- Age 19 and more
- Intervention with Onyx Drug Eluting Stent
- Agreed with written informed consent form
Who cannot join
- Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
South Korea31 sites
Hallym University Sacred Heart Hospital
Anyang
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Soon Chun Hyang University Hospital Cheonan
Cheonan
Gangwon National Univ. Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
Inje University Ilsan Paik Hospital
Ilsan
Presbyterian Medical Center
Jeonju
Kwangju Christian Hospital
Kwangju
Dong-A Medical Center
Pusan
Inje University Pusan Paik Hospital
Pusan
Pusan National University Hospital
Pusan
Bundang CHA Hospital
Seongnam
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Republic of Korea
Asan Medical Center
Seoul, Songpa-gu, 138-736
Gangnam Severance Hospital
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Kangdong Sacred Heart Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea St. Paul's Hospital
Seoul
St.carollo Hospital
Suncheon
Ulsan University Hospital
Ulsan
Wonju Severance Christian Hospital
Wŏnju
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases, Percutaneous Transluminal Angioplasty
- Being tested
- Onyx Drug Eluting Stent group
- Keywords
- Onyx, drug eluting stent, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onyx Drug Eluting Stent groupDevice
| Study group | Role | What they receive |
|---|---|---|
| Onyx Drug Eluting Stent | Not described Receives: Device: Onyx Drug Eluting Stent group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent thrombosis
As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis
Measured: 1 year
Secondary outcomes (11)
All death
Measured: 5 year
Cardiac death
Measured: 5 year
Myocardial infarction
Measured: 5 year
Composite event of death or myocardial infarction
Measured: 5 year
Composite event of cardiac death or myocardial infarction
Measured: 5 year
Composite event rate
death, myocardial infarction, target vessel revascularization
Measured: 5 year
Target Vessel revascularization
Measured: 5 year
Target Lesion revascularization
Measured: 5 year
Stent thrombosis
Measured: 5 year
Stroke
Measured: 5 year
Procedural success
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.
Measured: 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Medtronic Korea Co., Ltd.
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593994
- Sponsor's protocol ID
- AMCCV2015-04
- Acronym
- IRIS-Onyx
- Status last verified
- Jun 2026
- First submitted
- 30 Oct 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Resolute Onyx™ and Onyx Frontier™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02593994
- Acronym / sponsor ID
- IRIS-Onyx / AMCCV2015-04
- Conditions
- Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases, Percutaneous Transluminal Angioplasty
- Keywords
- Onyx, drug eluting stent, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Medtronic Korea Co., Ltd.
- Study start
- Oct 2015 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Onyx Drug Eluting Stent | – | Device: Onyx Drug Eluting Stent group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Onyx Drug Eluting Stent
Key inclusion criteria (3 listed)
- Age 19 and more
- Intervention with Onyx Drug Eluting Stent
- Agreed with written informed consent form
Key exclusion criteria (3 listed)
- Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onyx Drug Eluting Stent group | Device | Onyx Drug Eluting Stent |
Primary outcome
Stent thrombosis
Time frame: 1 year
As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis
11 secondary outcomes
All death
Time frame: 5 year
Cardiac death
Time frame: 5 year
Myocardial infarction
Time frame: 5 year
Composite event of death or myocardial infarction
Time frame: 5 year
Composite event of cardiac death or myocardial infarction
Time frame: 5 year
Composite event rate
Time frame: 5 year
Target Vessel revascularization
Time frame: 5 year
Target Lesion revascularization
Time frame: 5 year
Stent thrombosis
Time frame: 5 year
Stroke
Time frame: 5 year
Procedural success
Time frame: 3 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Arterial Occlusive Diseases, run by Seung-Jung Park at 31 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent thrombosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.