TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00569491
First received: December 6, 2007
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: TAXUS Express 2™
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee [ Time Frame: 30 days, 6 months, 2 years post-implant procedure ] [ Designated as safety issue: Yes ]
  • Rate of target vessel related cardiac events as classified by the Clinical Events Committee [ Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]
  • Rate of other TAXUS related events [ Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]

Enrollment: 2585
Study Start Date: February 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: TAXUS Express 2™
    TAXUS Express™ Paclitaxel-Eluting Coronary Stent System
    Other Name: TAXUS Express 2™
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Appropriate Patient Criteria:

  • Patient is eligible to receive a Boston Scientific TAXUS Stent.

Inappropriate Patients Criteria:

  • Known sensitivity to paclitaxel.
  • Known allergy to stainless steel.
  • Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
  • Patients with unresolved vessel thrombus at the lesion site.
  • Patients with coronary artery reference vessel diameters < 2.5 mm or > 3.75 mm.
  • Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
  • Patients with diffuse disease or poor overflow distal to the identified lesions.
  • Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
  • Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569491

  Show 50 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Eileen Rose, MS Boston Scientific Corporation
Principal Investigator: John M Lasala, MD, PhD Washington University School of Medicine
Principal Investigator: David A Cox, MD Lehigh Valley Physician Group
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kellie Windle, Clinical Project Manager, Boston Scientific
ClinicalTrials.gov Identifier: NCT00569491     History of Changes
Other Study ID Numbers: S2021
Study First Received: December 6, 2007
Last Updated: September 24, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014