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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014