Drug-Eluting Balloon Registry in Routine Clinical Practice (IRIS DEB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Angioplasty, Balloon
• Intervention / Treatment: Device: Balloon angioplasty

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• South Korea
  • Bucheon-si, South Korea
    • Terminated
    • Soon Chun Hyang University Hospital Bucheon
  • Daegu, South Korea
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Chang-wook Nam, MD
    • Contact: CHANG-WOOK NAM, MD; Email: cvcrc10@amc.seoul.kr
  • Daejeon, South Korea
    • Terminated
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gwangju, South Korea
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Young Joon Hong, MD; Email: cvcrc10@amc.seoul.kr
    • Principal Investigator: Young Joon Hong, MD
  • Pusan, South Korea
    • Recruiting
    • Dong-A Medical Center
    • Principal Investigator: Moo-Hyun Kim, MD
    • Contact: MOO-HYUN KIM, MD; Email: cvcrc10@amc.seoul.kr
  • Seoul, South Korea
    • Recruiting
    • Asan Medical Center
    • Contact: Seung-jung Park, MD; Email: sjpark@amc.seoul.kr
    • Principal Investigator: Seung-jung Park, MD
  • Seoul, South Korea
    • Recruiting
    • Gangnam Severance Hospital
    • Principal Investigator: Hyuck-moon Kwon, MD
    • Contact: Hyuck-moon Kwon, MD; Email: cvcrc10@amc.seoul.kr
  • Seoul, South Korea
    • Not yet recruiting
    • Korea University Guro Hospital
    • Principal Investigator: Seung-woon Rha, MD
    • Contact: Seung-woon Rha, MD
  • Ulsan, South Korea
    • Recruiting
    • Ulsan University Hospital
    • Contact: Eun Seok Shin, MD; Email: cvcrc10@amc.seoul.kr
    • Principal Investigator: Eun Seok Shin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with balloon angioplasty

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with coronary artery disease	Device: Balloon angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Event	Death, Non-fatal myocardial infarction, Target vessel revascularization	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		5year
Myocardial infarction		5year
Target lesion revascularization		5year
Stroke		5year
All cause death		5year
Composite event	Death or myocardial infarction	5year
Composite event	Cardiac death or myocardial infarction	5year
Target vessel revascularization		5year
Stent thrombosis	Classification of stent thrombosis according to Academic Research Consortium criteria	5year
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.	3day

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea; B. Braun Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimated): January 16, 2014

Study Record Updates

• Last Update Posted (Estimated): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Angioplasty, Balloon
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Angioplasty; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Angioplasty, Balloon
• Other Study ID Numbers: AMCCV2013-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.