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NCT Number: NCT02038660

Drug-Eluting Balloon Registry in Routine Clinical Practice

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.

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Key information

Conditions

Coronary Artery Disease Angioplasty, Balloon Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Balloon Angioplasty

Device

Primary outcomes

  1. Composite Event

    Time frame: 1year

    Death, Non-fatal myocardial infarction, Target vessel revascularization

Secondary outcomes

  1. All cause death

    Time frame: 5year

  2. Cardiac death

    Time frame: 5year

  3. Myocardial infarction

    Time frame: 5year

  4. Composite event

    Time frame: 5year

    Death or myocardial infarction

  5. Composite event

    Time frame: 5year

    Cardiac death or myocardial infarction

  6. Target vessel revascularization

    Time frame: 5year

  7. Target lesion revascularization

    Time frame: 5year

  8. Stent thrombosis

    Time frame: 5year

    Classification of stent thrombosis according to Academic Research Consortium criteria

  9. Stroke

    Time frame: 5year

  10. Procedural Success

    Time frame: 3day

    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.

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • B. Braun Korea Co., Ltd.
  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study

Acronym: IRIS DEB

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Jan 16, 2014
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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