Coronary Artery Disease
Conditions
Keywords
drug eluting stent, Percutaneous Coronary Intervention
Brief summary
The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.
Interventions
DEVICEXIENCE Skypoint™ stent
Percutaneous coronary intervention with Xience-Skypoint™ stent
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 19 years old 2. Patients receiving Xience-Skypoint™ stents. 3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Exclusion criteria
1. Patients with a mixture of other DESs 2. Terminal illness with life expectancy \<1 year 3. Patients with cardiogenic shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) | 12 months | the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the event rate of cardiac death | 5 years | — |
| the event rate of nonfatal myocardial infarction | 5 years | — |
| the composite event rate of death, or nonfatal myocardial infarction (MI) | 5 years | — |
| the composite event rate of cardiac death, or nonfatal myocardial infarction (MI) | 5 years | — |
| the event rate of all cause death | 5 years | — |
| the event rate of Target- lesion Revascularization (TLR) | 5 years | — |
| the event rate of stent thrombosis | 5 years | according to an Academic Research Consortium (ARC) criteria |
| the event rate of stroke | 5 years | — |
| the event rate of Procedural success | 7 days | (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. |
| the event rate of Target- Vessel Revascularization (TVR) | 5 years | — |
Countries
South Korea
Contacts
Primary ContactJung-hee Ham, Project manager
Outcome results
None listed