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Clinical Trials/NCT03967158
NCT03967158Active, not recruitingNot 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 enrollmentStarted: December 23, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
2,000
Locations
10
Primary Endpoint
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

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

  • •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)

Investigators

Sponsor
Seung-Jung Park
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

Professor, Division of Interventional Cardiology. Cardiovascular Center, Asan Medical Center. University of Ulsan, College of Medicine

Asan Medical Center

Study Sites (10)

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