NCT01186133RecruitingNot Applicable
Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
Seung-Jung Park2 sites in 2 countries50,000 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50,000
- Locations
- 2
- Primary Endpoint
- Composite 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 effectiveness and safety of the new drug-eluting stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the "real world" daily practice.
Detailed Description
Consecutive patients receiving New DES without a mixture of other DES
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
- •coronary disease amenable to percutaneous coronary intervention (PCI)
- •no clinical and lesion limitations
Exclusion Criteria
- •patients with a mixture of several DES
- •terminal illness with life expectancy less than 1 year
- •patients with cardiogenic shock
Outcomes
Primary Outcomes
Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time Frame: at 12 months post procedure
Secondary Outcomes
- Myocardial infarction(at 12 months and annually up to 5 years)
- Death (all-cause and cardiac)(at 12 months and annually up to 5 years)
- Stroke(at 12 months and annually up to 5 years)
- Target-lesion and target-vessel revascularization(at 12 months and annually up to 5 years)
- Stent thrombosis(at 12 months and annually up to 5 years)
- Procedural success(at 1 day)
Investigators
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
Study Sites (2)
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