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RecruitingNCT03588481IRIS DESyne X2Updated Jun 24, 2026

IRIS- DESyne X2 in the IRIS-DES Registry

An observational study in Coronary Stenosis, Coronary Occlusion and Coronary Disease, sponsored by Seung-Jung Park. Recruiting at 6 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

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

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.

02

Conditions studied

  • Coronary Stenosis
  • Coronary Occlusion
  • Coronary Disease

Keywords

  • PCI
  • DES
  • real world
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 with DeSyne X2 stent

Inclusion criteria

  • Age 19 and more
  • Intervention with DeSyne X2 drug-eluting coronary stent
  • Agreed with written informed consent form

Exclusion criteria

Exclusion Criteria:

  • Intervention with DeSyne X2 drug-eluting coronary stent and other drug eluting stent at the same time
  • Life expectancy of 1year and under
  • Cardiac shock
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Coronary stenosis

    Device: DESyne X2

Interventions

  • DeviceDESyne X2

    Novolimus-eluting stent

05

What researchers measure

Primary outcomes

  1. Composite event rate

    Death, non-fatal myocardial infarction, Target Vessel Revascularization

    Time frame: 1year

Secondary outcomes

  1. All death

    Time frame: 5years

  2. Cardiac death

    Time frame: 5years

  3. Myocardial infarction

    Time frame: 5years

  4. Composite event of death or myocardial infarction

    Time frame: 5years

  5. Composite event of cardiac death or myocardial infarction

    Time frame: 5years

  6. Target Vessel revascularization

    Time frame: 5years

  7. Target Lesion revascularization

    Time frame: 5years

  8. Stent thrombosis

    stent thrombosis as classified by an Academic Research Consortium

    Time frame: 5years

  9. Stroke

    Time frame: 5years

  10. 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: 3days

06

Study locations

2 of 6 sites recruiting
  • Hallym Hospital
    Incheon, South Korea
    • Soo-han Kim, MD · Contact
    • Soo-han Kim, MD · Principal investigator
    Recruiting
  • Asan Medical Hospital
    Seoul, South Korea
    • Seung-jung Park, MD · Contact
    • Seung-jung Park, MD · Principal investigator
    Recruiting
  • Korea University Guro Hospital
    Seoul, South Korea
    Terminated
  • The Catholic University of Korea Seoul St. Mary's Hospital
    Seoul, South Korea
    Withdrawn
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Seoul, South Korea
    Terminated
  • St.carollo Hospital
    Suncheon, South Korea
    Terminated
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
NCT03588481
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center) — Sponsor-investigator
First posted
Jul 17, 2018
Start date
Nov 28, 2018
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Jun 24, 2026

Study contacts

Jung-hee Ham, RN
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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