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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: TAXUS Express 2™

• Study Type: Interventional
• Enrollment (Actual): 2585
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85233
      • Advanced Cardiac Specialists
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Cardiology Associates of NEA
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • Salinas, California, United States, 93901
      • Salinas Valley Memorial Hospital
    • San Jose, California, United States, 95124
      • Good Samaritan
    • Torrance, California, United States, 90503
      • Little Company of Mary Hospital
  • Colorado
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Juniper, Florida, United States, 33458
      • Advanced Clinical Research Group, LLC
    • Orlando, Florida, United States, 32803
      • Florida Heart Institute
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Macon, Georgia, United States, 31208
      • Georgia Heart and Vascular Center
  • Illinois
    • Elk Grove, Illinois, United States, 60007
      • Alexian Brothers Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Hospital/NIRA
    • Indianapolis, Indiana, United States, 46237
      • St Francis Hospital
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Medical Center
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Our Lady of Lourdes
    • Shreveport, Louisiana, United States, 71103
      • Willis Knighton Medical Center
  • Maine
    • Bangor, Maine, United States, 04401
      • Northeast Cardiology Associates
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Delmarva Heart Research Foundation, Inc
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Regional Cardiology Associates
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metro Cardiology Consultants
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Cardiovascular Consultants of Nevada
  • New Jersey
    • Morristown, New Jersey, United States, 07079
      • Morristown Memorial
  • New York
    • Valhalla, New York, United States, 10595
      • Westchester County Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associates, PA
    • Charlotte, North Carolina, United States, 28204
      • Mid-Carolina Cardiology Presbyterian Hospital
    • Greenville, North Carolina, United States, 27858
      • Pitt County Memorial Hospital
    • Raleigh, North Carolina, United States, 27610
      • WakeMed - Wake Heart Associates
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Fairview Park, Ohio, United States, 44126
      • Cleveland Cardiovascular Research Foundation
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Presbyterian University of Pennsylvania Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital Systems
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Heart Hospital of South Dakota
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Cardiovascular Associates, Pc
  • Texas
    • Dallas, Texas, United States, 75265
      • Methodist Dallas Medical Center
    • Lubbock, Texas, United States, 79410
      • Texas Cardiac Center
    • San Antonio, Texas, United States, 78229
      • South Texas Cardiovascular Consultants
    • Tyler, Texas, United States, 75702
      • Trinity Mother Frances Hospital
    • Webster, Texas, United States, 77598
      • Clear Lake Regional Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22041
      • Inova Fairfax Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • Hope Heart Institute
    • Olympia, Washington, United States, 98506
      • St. Peters Hospital
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St Mary's Hospital
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • CaRE Foundation, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee	1 year post-implant procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee	30 days, 6 months, 2 years post-implant procedure
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

Collaborators and Investigators

• Sponsor: 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 and helpful links

General Publications

• Brilakis ES, Lasala JM, Cox DA, Berger PB, Bowman TS, Starzyk RM, Dawkins KD. Outcomes after implantation of the TAXUS paclitaxel-eluting stent in saphenous vein graft lesions: results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program. JACC Cardiovasc Interv. 2010 Jul;3(7):742-50. doi: 10.1016/j.jcin.2010.04.012.
• Lasala JM, Cox DA, Dobies D, Baran K, Bachinsky WB, Rogers EW, Breall JA, Lewis DH, Song A, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS; ARRIVE 1 and ARRIVE 2 Participating Physicians. Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries. Circ Cardiovasc Interv. 2009 Aug;2(4):285-93. doi: 10.1161/CIRCINTERVENTIONS.109.852178.109.852178. Epub 2009 Jul 22.
• Lasala JM, Cox DA, Lewis SJ, Tadros PN, Haas RC, Schweiger MJ, Chhabra A, Untereker WJ, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS. Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme. EuroIntervention. 2009 May;5(1):67-77. doi: 10.4244/eijv5i1a11.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: December 6, 2007
• First Submitted That Met QC Criteria: December 6, 2007
• First Posted (Estimate): December 7, 2007

Study Record Updates

• Last Update Posted (Estimate): September 25, 2008
• Last Update Submitted That Met QC Criteria: September 24, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: S2021