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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; de Novo Coronary Lesions
• Intervention / Treatment: Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System

• Study Type: Interventional
• Enrollment (Actual): 5016
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Healthcare
  • California
    • Bakersfield, California, United States, 93301
      • Bakersfield Memorial Hospital
    • Rancho Mirage, California, United States, 92270
      • Desert Cardiology Consultants
    • San Francisco, California, United States, 94115
      • Kaiser San Francisco
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Saint Vincent's Medical Center
    • Melbourne, Florida, United States, 32901
      • Health First Clinical Research Institute
    • Pensacola, Florida, United States, 32504
      • Cardiology Consultants
    • St. Petersburg, Florida, United States, 33705
      • The Heart And Vascular Institute Of Florida
  • Idaho
    • Boise, Idaho, United States, 83704
      • Idaho Cardiology Associates
  • Illinois
    • Lombard, Illinois, United States, 60148
      • Midwest Heart Foundation
    • Merrionette Park, Illinois, United States, 60803
      • Heart Care Research Foundation
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • The Indiana Heart Hospital
    • Indianapolis, Indiana, United States, 46202
      • Krannert Institute of Cardiology
    • Munster, Indiana, United States, 46321
      • Community Hospital
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Heart Center Research
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • CHRISTUS St. Frances Cabrini Hospital
    • Baton Rouge, Louisiana, United States, 70808
      • Cardiovascular Research Foundation of Louisiana
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
    • Worcester, Massachusetts, United States, 01608
      • St. Vincent Hospital at Worcester Medical Center
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Thoracic & Cardiovascular Healthcare Foundation
    • St. Joseph, Michigan, United States, 49085
      • Great Lakes Heart and Vascular Institute
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Heart and Vascular Center
    • St. Paul, Minnesota, United States, 55102
      • St. Paul Heart Clinic
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Barnes / Jewish (Washington University)
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • The Creighton Cardiac Center
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of Delaware Valley
    • Neptune, New Jersey, United States, 07754
      • Jersey Shore University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute, PA
  • New York
    • New York, New York, United States, 10011
      • Saint Vincent's Catholic Medical Center of New York
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mid-Carolina Cardiology Presbyterian Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Columbus, Ohio, United States, 43215
      • HeartCare, Inc
    • Parma, Ohio, United States, 44129
      • Parma Community General Hospital
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74114
      • Heart Center of Tulsa
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Pittsburgh, Pennsylvania, United States, 15224
      • The Western Pennsylvania Hospital
    • Wormleysburg, Pennsylvania, United States, 17043
      • Moffitt Heart and Vascular Group
    • Wynnewood, Pennsylvania, United States, 19096
      • Main Line Health Center
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Baptist Heart Institute
    • Nashville, Tennessee, United States, 37205
      • St. Thomas Research Institute
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Heart Center of North Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • McAllen, Texas, United States, 78504
      • Spectra Clinical Research Management Group
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Bellingham, Washington, United States, 98225
      • North Cascade Cardiology, PLLC
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54305-2425
      • Cardiology Associates of Green Bay
    • Madison, Wisconsin, United States, 53715
      • South Central Wisconsin Heart

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 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.

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 as classified by the Clinical Events Committee (CEC).	1-year post-implant procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of other TAXUS related events	30 days, 6 months, 1 and 2 years post-implant procedure
Rate of TAXUS stent related cardiac events as classified by the CEC.	within 30 days, 6 months and 2 years
Rate of target vessel related cardiac events as classified by the CEC.	30 days, at 6 months, at 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: October 1, 2004
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): July 1, 2008

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 29, 2008
• Last Update Submitted That Met QC Criteria: September 25, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: coronary artery disease; coronary disease; coronary; de novo
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: S2200 (Other Identifier: CTEP)