NCT01134159CompletedNot Applicable
Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V
Medstar Health Research Institute10 sites in 1 country1,200 target enrollmentStarted: June 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,200
- Locations
- 10
- Primary Endpoint
- Major adverse cardiac events,
Study Overview
Brief Summary
Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major adverse cardiac events in patients whom have undergone percutaneous coronary intervention and received either Taxus Liberte or Xience V.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18 years of age or older, both genders
- •Underwent PCI with Taxus Liberte (alone) or Xience (alone)
Exclusion Criteria
- •Underwent PCI with a non-Taxus Liberte or Xience V DES during the same procedure
- •Received both Taxus-Liberte and Xience-V during the same index procedure
- •Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel).
Outcomes
Primary Outcomes
Major adverse cardiac events,
Time Frame: 1 year
A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization
Secondary Outcomes
- Stent thrombosis(1 year)
- Target vessel revascularization(1 year)
- Cardiac death(1 year)
Investigators
Study Sites (10)
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