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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

From the registry’s dates

  • Started Nov 2018; still recruiting 7 years 11 months later.
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

In context

Coronary Stenosis

326 studies on the registry are indexed under Coronary Stenosis; 57 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 125 observational studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Intervention with DeSyne X2 drug-eluting coronary stent and other drug eluting stent at the same time
  • of 1year and under
  • Cardiac shock
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

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

06

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

07

Study locations

2 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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