NCT00569491CompletedPhase 4
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
Boston Scientific Corporation100 sites in 1 country2,585 target enrollmentStarted: February 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 2,585
- Locations
- 100
- Primary Endpoint
- Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee
Study Overview
Brief Summary
The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee
Time Frame: 1 year post-implant procedure
Secondary Outcomes
- Rate of target vessel related cardiac events as classified by the Clinical Events Committee(30 days, 6 months, 1 and 2 years post-implant procedure)
- Rate of other TAXUS related events(30 days, 6 months, 1 and 2 years post-implant procedure)
- Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee(30 days, 6 months, 2 years post-implant procedure)
Investigators
Study Sites (100)
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