Angioplasty, Balloon, Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Angioplasty, Balloon
Brief 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.
Interventions
DEVICEBalloon angioplasty
Sponsors
CardioVascular Research Foundation, Korea
B. Braun Korea Co., Ltd.
Seung-Jung Park
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Event | 1year | Death, Non-fatal myocardial infarction, Target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 5year | — |
| Myocardial infarction | 5year | — |
| Composite event | 5year | Death or myocardial infarction |
| Target vessel revascularization | 5year | — |
| All cause death | 5year | — |
| Stent thrombosis | 5year | Classification of stent thrombosis according to Academic Research Consortium criteria |
| Stroke | 5year | — |
| Procedural Success | 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. |
| Target lesion revascularization | 5year | — |
Countries
South Korea
Outcome results
None listed