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RecruitingNCT02038660IRIS DEBUpdated Dec 29, 2025

Drug-Eluting Balloon Registry in Routine Clinical Practice

An observational study in Coronary Artery Disease and Angioplasty, Balloon, sponsored by Seung-Jung Park. Recruiting at 9 sites in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Seung-Jung Park · Observational

From the registry’s dates

  • Started Jan 2014; still recruiting 12 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.

02

Conditions studied

  • Coronary Artery Disease
  • Angioplasty, Balloon

Keywords

  • Coronary Artery Disease
  • Angioplasty, Balloon
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

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

04

Who can participate

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

Study population

Patients treated with balloon angioplasty

Inclusion criteria

  • After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow
  • Age 20 and more
  • Treated with Balloon angioplasty
  • Signed informed consent and agreed to follow protocol

Exclusion criteria

Exclusion Criteria:

  • Allergy to paclitaxel, antiplatelet
  • History of side effect to heparin, aspirin, thienopyridines
  • History of bleeding tendency, coagulation disorder, blood transfusion reaction
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with coronary artery disease

    Device: Balloon angioplasty

Interventions

  • DeviceBalloon angioplasty
06

What researchers measure

Primary outcomes

  1. Composite Event

    Death, Non-fatal myocardial infarction, Target vessel revascularization

    Time frame: 1year

Secondary outcomes

  1. All cause death

    Time frame: 5year

  2. Cardiac death

    Time frame: 5year

  3. Myocardial infarction

    Time frame: 5year

  4. Composite event

    Death or myocardial infarction

    Time frame: 5year

  5. Composite event

    Cardiac death or myocardial infarction

    Time frame: 5year

  6. Target vessel revascularization

    Time frame: 5year

  7. Target lesion revascularization

    Time frame: 5year

  8. Stent thrombosis

    Classification of stent thrombosis according to Academic Research Consortium criteria

    Time frame: 5year

  9. Stroke

    Time frame: 5year

  10. 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.

    Time frame: 3day

07

Study locations

6 of 9 sites recruiting
  • Soon Chun Hyang University Hospital Bucheon
    Bucheon-si, South Korea
    Terminated
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    Recruiting
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital
    Daejeon, South Korea
    Terminated
  • Chonnam National University Hospital
    Gwangju, South Korea
    Recruiting
  • Dong-A Medical Center
    Pusan, South Korea
    Recruiting
  • Asan Medical Center
    Seoul, South Korea
    • SEUNG-JUNG PARK, MD · Contact · sjpark@amc.seoul.kr
    • SEUNG-JUNG PARK, MD · Principal investigator
    Recruiting
  • Gangnam Severance Hospital
    Seoul, South Korea
    Recruiting
  • Korea University Guro Hospital
    Seoul, South Korea
    • Seung-woon Rha, MD · Contact
    • Seung-woon Rha, MD · Principal investigator
    Not yet recruiting
  • Ulsan University Hospital
    Ulsan, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — This is not a publicly funded trial.

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 Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02038660
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea, B. Braun Korea Co., Ltd.
Responsible party
Seung-Jung Park (MD,PhD, Asan Medical Center) — Sponsor-investigator
First posted
Jan 16, 2014
Start date
Jan 2014
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Dec 29, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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