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TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00569751
First received: December 6, 2007
Last updated: September 25, 2008
Last verified: September 2008

December 6, 2007
September 25, 2008
October 2004
November 2006   (final data collection date for primary outcome measure)
Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). [ Time Frame: 1-year post-implant procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00569751 on ClinicalTrials.gov Archive Site
  • Rate of TAXUS stent related cardiac events as classified by the CEC. [ Time Frame: within 30 days, 6 months and 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ 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 ]
Same as current
Not Provided
Not Provided
 
TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cardiovascular Disease
  • de Novo Coronary Lesions
Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
Drug Eluting Stent used to treat de novo coronary artery lesions.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5016
July 2008
November 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00569751
S2200
No
Kellie Windle, Clinical Project Manager, Boston Scientific
Boston Scientific Corporation
Not Provided
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
Boston Scientific Corporation
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP