a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥ 19 years old
- •Patients receiving Xience-Skypoint™ stents.
- •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
- •Patients with a mixture of other DESs
- •Terminal illness with life expectancy <1 year
- •Patients with cardiogenic shock
Outcomes
Primary Outcomes
the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time Frame: 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 Outcomes
- the event rate of Target- lesion Revascularization (TLR)(5 years)
- the event rate of all cause death(5 years)
- the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)(5 years)
- 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 event rate of Target- Vessel Revascularization (TVR)(5 years)
- the event rate of stent thrombosis(5 years)
- the event rate of stroke(5 years)
- the event rate of Procedural success(7 days)
Investigators
Seung-Jung Park
Professor, Department of Cardiology, University of Ulsan College of Medicine
Asan Medical Center