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RecruitingNCT06177743IRIS CoroflexUpdated Jun 25, 2026

IRIS-Coroflex NEO Cohort

An observational study in Coronary Artery Stenosis and Coronary Artery Disease, sponsored by Seung-Jung Park. Recruiting at 11 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Seung-Jung Park · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Stenosis
  • Coronary Artery Disease

Keywords

  • percutaneous coronary intervention
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving Coroflex ISAR NEO stents.

Inclusion criteria

  1. Patients ≥ 19 years old
  2. Patients receiving Coroflex ISAR NEO stents.
  3. 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a mixture of other DESs
  2. Terminal illness with life expectancy \<1 year.
  3. Patients with cardiogenic shock
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Coroflex ISAR NEO

    Patients receiving percutaneous coronary intervention with Coroflex ISAR NEO stents

    Device: Coroflex ISAR NEO stent

Interventions

  • DeviceCoroflex ISAR NEO stent

    Percutaneous coronary intervention with Coroflex ISAR NEO stent

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. the event rate of all cause death

    Time frame: 5 years

  2. the event rate of cardiac death

    Time frame: 5 years

  3. the event rate of myocardial infarction

    Time frame: 5 years

  4. the composite event rate of death, or myocardial infarction (MI)

    Time frame: 5 years

  5. the composite event rate of cardiac death, or myocardial infarction (MI)

    Time frame: 5 years

  6. the event rate of Target- Vessel Revascularization (TVR)

    Time frame: 5 years

  7. the event rate of Target- lesion Revascularization (TLR)

    Time frame: 5 years

  8. the event rate of stent thrombosis

    according to an Academic Research Consortium (ARC) criteria

    Time frame: 5 years

  9. the event rate of stroke

    Time frame: 5 years

  10. 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.

    Time frame: 5 days

06

Study locations

7 of 11 sites recruiting
  • Asan Medical Center
    Seoul, Songpa-gu 138-736, South Korea
    • Seung-jung Park, MD, PhD · Contact
    • Seung-jung Park, MD, PhD · Principal investigator
    Recruiting
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
    • Ha-wook Park, MD · Contact
    • Ha-wook Park, MD · Principal investigator
    Recruiting
  • The Catholic Univ. of Korea BUCHEON ST.Mary's hospital
    Bucheon-si, South Korea
    • Dong-bin Kim, MD · Contact
    • Dong-bin Kim, MD · Principal investigator
    Recruiting
  • Veterans Hospital
    Daegu, South Korea
    • Sang-wook Kang, MD · Contact
    • Sang-wook Kang, MD · Principal investigator
    Recruiting
  • Chonnam National University Hospital
    Gwangju, South Korea
    • Young-joon Hong, MD · Contact
    • Young-joon Hong, MD · Principal investigator
    Not yet recruiting
  • Inje University Ilsan Paik Hospital
    Ilsan, South Korea
    • Joon-hyung Do, MD · Contact
    • Joon-hyung Do, MD · Principal investigator
    Not yet recruiting
  • Myongji Hospital
    Ilsan, South Korea
    • Yoon-Hyoung Cho, MD · Contact
    • Yoon-Hyoung Cho, MD · Principal investigator
    Recruiting
  • Sejong Chungnam National University Hospital
    Sejong, South Korea
    • Jae-Hyung No, MD · Contact
    • Jae-Hyung No, MD · Principal investigator
    Recruiting
  • Seoul National University Boramae Medical Center
    Seoul, South Korea
    • Sang-hyun Kim, MD · Contact
    • Sang-hyun Kim, MD · Principal investigator
    Not yet recruiting
  • The Catholic university of Korea, ST. Vincent's Hospital
    Suwon, South Korea
    • Dong-kyu Moon, MD · Contact
    • Dong-kyu Moon, MD · Principal investigator
    Recruiting
  • Uijeongbu Eulji Medical Center
    Uijeongbu-si, South Korea
    Withdrawn
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06177743
Lead sponsor
Seung-Jung Park
Collaborators
The CardioVascular Research Foundation (CVRF)
Responsible party
Seung-Jung Park (professor, Asan Medical Center) — Sponsor-investigator
First posted
Dec 20, 2023
Start date
Jan 9, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Jun 25, 2026

Study contacts

Jung-Hee Ham, Project manager
Contact
cvcrc5@amc.seoul.kr
82230104728

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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