Coronary Disease, Coronary Occlusion, Coronary Stenosis
Conditions
Keywords
PCI, DES, real world
Brief summary
This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.
Interventions
DEVICEDESyne X2
Novolimus-eluting stent
Sponsors
Seung-Jung Park
CardioVascular Research Foundation, Korea
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 DeSyne X2 drug-eluting coronary stent * Agreed with written informed consent form
Exclusion criteria
* Intervention with DeSyne X2 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 |
|---|---|---|
| Composite event rate | 1year | Death, non-fatal myocardial infarction, Target Vessel Revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All death | 5years | — |
| Cardiac death | 5years | — |
| Myocardial infarction | 5years | — |
| Composite event of death or myocardial infarction | 5years | — |
| Composite event of cardiac death or myocardial infarction | 5years | — |
| Target Vessel revascularization | 5years | — |
| Target Lesion revascularization | 5years | — |
| Stent thrombosis | 5years | stent thrombosis as classified by an Academic Research Consortium |
| Stroke | 5years | — |
| Procedural success | 3days | defined as achievement of a final diameter stenosis of \<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization. |
Countries
South Korea
Contacts
CONTACTJung-hee Ham, RN
Outcome results
None listed