Coronary Artery StenosisIRIS CoroflexNCT06177743
IRIS-Coroflex NEO Cohort
An observational study of Coronary Artery Stenosis and Coronary Artery Disease, run by Seung-Jung Park at 11 sites in South Korea.
Trial summary
The objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Stenosis, Coronary Artery Disease
- What is being tested?
- Coroflex ISAR NEO stent
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 9 Jan 2025to 31 Dec 2032
- How long will I take part?
- 5 Years
- 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 receiving Coroflex ISAR NEO stents.
Who may be able to join
- Patients ≥ 19 years old
- Patients receiving Coroflex ISAR NEO stents.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Who cannot join
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year.
- Patients with cardiogenic shock
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
South Korea11 sites, 10 recruiting
- Recruiting
Bucheon Sejong Hospital
Bucheon-si
Ha-wook Park, MD
Ha-wook Park, MD
- Recruiting
The Catholic Univ. of Korea BUCHEON ST.Mary's hospital
Bucheon-si
Dong-bin Kim, MD
Dong-bin Kim, MD
- Recruiting
Veterans Hospital
Daegu
Sang-wook Kang, MD
Sang-wook Kang, MD
- Not yet recruiting
Chonnam National University Hospital
Gwangju
Young-joon Hong, MD
Young-joon Hong, MD
- Not yet recruiting
Inje University Ilsan Paik Hospital
Ilsan
Joon-hyung Do, MD
Joon-hyung Do, MD
- Recruiting
Myongji Hospital
Ilsan
Yoon-Hyoung Cho, MD
Yoon-Hyoung Cho, MD
- Recruiting
Sejong Chungnam National University Hospital
Sejong
Jae-Hyung No, MD
Jae-Hyung No, MD
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 138-736
Seung-jung Park, MD, PhD
Seung-jung Park, MD, PhD
- Not yet recruiting
Seoul National University Boramae Medical Center
Seoul
Sang-hyun Kim, MD
Sang-hyun Kim, MD
- Recruiting
The Catholic university of Korea, ST. Vincent's Hospital
Suwon
Dong-kyu Moon, MD
Dong-kyu Moon, MD
- Withdrawn
Uijeongbu Eulji Medical Center
Uijeongbu-si
About this study
Official title: Evaluation of Effectiveness and Safety of Coroflex ISAR NEO Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
The objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.
- Conditions
- Coronary Artery Stenosis, Coronary Artery Disease
- Being tested
- Coroflex ISAR NEO stent
- Keywords
- percutaneous coronary intervention
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coroflex ISAR NEO stentDevice
Percutaneous coronary intervention with Coroflex ISAR NEO stent
| Study group | Role | What they receive |
|---|---|---|
| Coroflex ISAR NEO | Patients receiving percutaneous coronary intervention with Coroflex ISAR NEO stents Receives: Device: Coroflex ISAR NEO stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure.
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
Measured: 12 months
Secondary outcomes (10)
the event rate of all cause death
Measured: 5 years
the event rate of cardiac death
Measured: 5 years
the event rate of myocardial infarction
Measured: 5 years
the composite event rate of death, or myocardial infarction (MI)
Measured: 5 years
the composite event rate of cardiac death, or myocardial infarction (MI)
Measured: 5 years
the event rate of Target- Vessel Revascularization (TVR)
Measured: 5 years
the event rate of Target- lesion Revascularization (TLR)
Measured: 5 years
the event rate of stent thrombosis
according to an Academic Research Consortium (ARC) criteria
Measured: 5 years
the event rate of stroke
Measured: 5 years
the event rate of Procedural success
defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start9 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies 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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- The CardioVascular Research Foundation (CVRF)
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177743
- Sponsor's protocol ID
- AMCCV2023-05
- Acronym
- IRIS Coroflex
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Coroflex ISAR NEO Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06177743
- Acronym / sponsor ID
- IRIS Coroflex / AMCCV2023-05
- Conditions
- Coronary Artery Stenosis, Coronary Artery Disease
- Keywords
- percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- The CardioVascular Research Foundation (CVRF)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 20 Dec 2023 (actual)
- 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 objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coroflex ISAR NEO | – | Device: Coroflex ISAR NEO stentPatients receiving percutaneous coronary intervention with Coroflex ISAR NEO stents |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Coroflex ISAR NEO stents.
Key inclusion criteria (3 listed)
- Patients ≥ 19 years old
- Patients receiving Coroflex ISAR NEO stents.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Key exclusion criteria (3 listed)
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year.
- Patients with cardiogenic 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 |
|---|---|---|
| Coroflex ISAR NEO stentPercutaneous coronary intervention with Coroflex ISAR NEO stent | Device | Coroflex ISAR NEO |
Primary outcome
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time frame: 12 months
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
10 secondary outcomes
the event rate of all cause death
Time frame: 5 years
the event rate of cardiac death
Time frame: 5 years
the event rate of myocardial infarction
Time frame: 5 years
the composite event rate of death, or myocardial infarction (MI)
Time frame: 5 years
the composite event rate of cardiac death, or myocardial infarction (MI)
Time frame: 5 years
the event rate of Target- Vessel Revascularization (TVR)
Time frame: 5 years
the event rate of Target- lesion Revascularization (TLR)
Time frame: 5 years
the event rate of stent thrombosis
Time frame: 5 years
the event rate of stroke
Time frame: 5 years
the event rate of Procedural success
Time frame: 5 days
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 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
11 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 Stenosis and Coronary Artery Disease, run by Seung-Jung Park at 11 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: looking for participants now, as of the sponsor's last update on 25 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 11 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?
Contact Jung-Hee Ham, Project manager (82230104728, cvcrc5@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) (time frame: 12 months). 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 25 Jun 2026.