Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease, Percutaneous Transluminal Angioplasty
Conditions
Keywords
Onyx, drug eluting stent, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
Brief summary
The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.
Interventions
DEVICEOnyx Drug Eluting Stent group
Sponsors
Seung-Jung Park
CardioVascular Research Foundation, Korea
Medtronic Korea Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 19 and more * Intervention with Onyx Drug Eluting Stent * Agreed with written informed consent form
Exclusion criteria
* Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time * Life expectancy of 1year and under * Cardiac shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis | 1 year | As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All death | 5 year | — |
| Cardiac death | 5 year | — |
| Myocardial infarction | 5 year | — |
| Composite event of death or myocardial infarction | 5 year | — |
| Composite event of cardiac death or myocardial infarction | 5 year | — |
| Composite event rate | 5 year | death, myocardial infarction, target vessel revascularization |
| Target Vessel revascularization | 5 year | — |
| Target Lesion revascularization | 5 year | — |
| Stent thrombosis | 5 year | — |
| Stroke | 5 year | — |
| Procedural success | 3 day | 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. |
Countries
South Korea
Outcome results
None listed