NCT03967158
Active, not recruiting
Not Applicable
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY
Seung-Jung Park10 sites in 1 country2,000 target enrollmentDecember 23, 2019
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Seung-Jung Park
- Enrollment
- 2000
- Locations
- 10
- Primary Endpoint
- Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.
Investigators
Seung-Jung Park
Professor, Division of Interventional Cardiology. Cardiovascular Center, Asan Medical Center. University of Ulsan, College of Medicine
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age 19 and more
- •Patient with Xience Sierra Everolimus eluting coronary stent
- •Written consent
Exclusion Criteria
- •Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time
- •Life-expectancy less than 1 year
- •Cardiac shock
Outcomes
Primary Outcomes
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Time Frame: 1 year
Secondary Outcomes
- Target- Lesion Revascularization(5 year)
- Myocardial Infarction(5 year)
- Stent thrombosis(5 year)
- Target- Vessel Revascularization(5 year)
- Cardiac death(5 year)
- Composite event rate of cardiac death or myocardial infarction (MI)(5 year)
- Stroke(5 year)
- All cause death(5 year)
- Procedural Success rate(5 year)
- Composite event rate of death or myocardial infarction (MI)(5 year)
Study Sites (10)
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