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TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program (ARRIVE 2)

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ClinicalTrials.gov Identifier: NCT00569751
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : September 29, 2008
Sponsor:
Information provided by:
Boston Scientific Corporation

Brief Summary:
The TAXUS ARRIVE 2 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 or disease Intervention/treatment Phase
Cardiovascular Disease de Novo Coronary Lesions Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5016 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
Study Start Date : October 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : July 2008

Intervention Details:
    Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
    Drug Eluting Stent used to treat de novo coronary artery lesions.


Primary Outcome Measures :
  1. Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). [ Time Frame: 1-year post-implant procedure ]

Secondary Outcome Measures :
  1. Rate of TAXUS stent related cardiac events as classified by the CEC. [ Time Frame: within 30 days, 6 months and 2 years ]
  2. Rate of target vessel related cardiac events as classified by the CEC. [ Time Frame: 30 days, at 6 months, at 1 and 2 years post-implant procedure ]
  3. Rate of other TAXUS related events [ Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Appropriate Patient Criteria:

  • Patient is eligible to receive a Boston Scientific TAXUS Stent

Inappropriate Patient 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 less than 2.5 mm or greater than 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569751


  Show 53 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kellie Windle, Clinical Project Manager, Boston Scientific
ClinicalTrials.gov Identifier: NCT00569751     History of Changes
Other Study ID Numbers: S2200
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

Keywords provided by Boston Scientific Corporation:
de novo
coronary
coronary artery disease
coronary disease

Additional relevant MeSH terms:
Cardiovascular Diseases