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Clinical Trials/NCT00569491
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

Sponsor Class
Industry

Study Sites (100)

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