Coronary Artery Disease Clinical Trial
— IRIS DEBOfficial title:
Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
| NCT number | NCT02038660 |
| Other study ID # | AMCCV2013-10 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2014 |
| Est. completion date | June 2028 |
| Verified date | December 2023 |
| Source | Asan Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 1500 |
| Est. completion date | June 2028 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Soon Chun Hyang University Hospital Bucheon | Bucheon | |
| Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
| Korea, Republic of | The Catholic University of Korea, Daejeon ST. Mary's Hospital | Daejeon | |
| Korea, Republic of | Dong-A Medical Center | Pusan | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Gangnam Severance Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Ulsan University Hospital | Ulsan |
| Lead Sponsor | Collaborator |
|---|---|
| Seung-Jung Park | B. Braun Korea Co., Ltd., CardioVascular Research Foundation, Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite Event | Death, Non-fatal myocardial infarction, Target vessel revascularization | 1year | |
| Secondary | All cause death | 5year | ||
| Secondary | Cardiac death | 5year | ||
| Secondary | Myocardial infarction | 5year | ||
| Secondary | Composite event | Death or myocardial infarction | 5year | |
| Secondary | Composite event | Cardiac death or myocardial infarction | 5year | |
| Secondary | Target vessel revascularization | 5year | ||
| Secondary | Target lesion revascularization | 5year | ||
| Secondary | Stent thrombosis | Classification of stent thrombosis according to Academic Research Consortium criteria | 5year | |
| Secondary | Stroke | 5year | ||
| Secondary | 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 |
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