Coronary Artery DiseaseIRIS DEBNCT02038660
Drug-Eluting Balloon Registry in Routine Clinical Practice
An observational study of Coronary Artery Disease and Angioplasty, Balloon, run by Seung-Jung Park at 9 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Angioplasty, Balloon
- What is being tested?
- Balloon angioplasty
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Jan 2014to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with balloon angioplasty
Who may be able to join
- 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
Who cannot join
- Allergy to paclitaxel, antiplatelet
- History of side effect to heparin, aspirin, thienopyridines
- History of bleeding tendency, coagulation disorder, blood transfusion reaction
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
South Korea9 sites, 7 recruiting
- Terminated
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
CHANG-WOOK NAM, MD, cvcrc10@amc.seoul.kr
CHANG-WOOK NAM, MD
- Terminated
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
- Recruiting
Chonnam National University Hospital
Gwangju
Young Joon Hong, MD, cvcrc10@amc.seoul.kr
Young Joon Hong, MD
- Recruiting
Dong-A Medical Center
Pusan
MOO-HYUN KIM, MD, cvcrc10@amc.seoul.kr
MOO-HYUN KIM, MD
- Recruiting
Asan Medical Center
Seoul
SEUNG-JUNG PARK, MD, sjpark@amc.seoul.kr
SEUNG-JUNG PARK, MD
- Recruiting
Gangnam Severance Hospital
Seoul
Hyuck-moon Kwon, MD, cvcrc10@amc.seoul.kr
Hyuck-moon Kwon, MD
- Not yet recruiting
Korea University Guro Hospital
Seoul
Seung-woon Rha, MD
Seung-woon Rha, MD
- Recruiting
Ulsan University Hospital
Ulsan
Eun Seok Shin, MD, cvcrc10@amc.seoul.kr
Eun Seok Shin, MD
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease, Angioplasty, Balloon
- Being tested
- Balloon angioplasty
- Keywords
- Coronary Artery Disease, Angioplasty, Balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon angioplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary artery disease | Not described Receives: Device: Balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Event
Death, Non-fatal myocardial infarction, Target vessel revascularization
Measured: 1year
Secondary outcomes (10)
All cause death
Measured: 5year
Cardiac death
Measured: 5year
Myocardial infarction
Measured: 5year
Composite event
Death or myocardial infarction
Measured: 5year
Composite event
Cardiac death or myocardial infarction
Measured: 5year
Target vessel revascularization
Measured: 5year
Target lesion revascularization
Measured: 5year
Stent thrombosis
Classification of stent thrombosis according to Academic Research Consortium criteria
Measured: 5year
Stroke
Measured: 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.
Measured: 3day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, B. Braun Korea Co., Ltd.
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038660
- Sponsor's protocol ID
- AMCCV2013-10
- Acronym
- IRIS DEB
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2014
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02038660
- Acronym / sponsor ID
- IRIS DEB / AMCCV2013-10
- Conditions
- Coronary Artery Disease, Angioplasty, Balloon
- Keywords
- Coronary Artery Disease, Angioplasty, Balloon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, B. Braun Korea Co., Ltd.
- Study start
- Jan 2014 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary artery disease | – | Device: Balloon angioplasty |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with balloon angioplasty
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Allergy to paclitaxel, antiplatelet
- History of side effect to heparin, aspirin, thienopyridines
- History of bleeding tendency, coagulation disorder, blood transfusion reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon angioplasty | Device | Patients with coronary artery disease |
Primary outcome
Composite Event
Time frame: 1year
Death, Non-fatal myocardial infarction, Target vessel revascularization
10 secondary outcomes
All cause death
Time frame: 5year
Cardiac death
Time frame: 5year
Myocardial infarction
Time frame: 5year
Composite event
Time frame: 5year
Composite event
Time frame: 5year
Target vessel revascularization
Time frame: 5year
Target lesion revascularization
Time frame: 5year
Stent thrombosis
Time frame: 5year
Stroke
Time frame: 5year
Procedural Success
Time frame: 3day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angioplasty, Balloon, run by Seung-Jung Park at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Event (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.