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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569751
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : September 29, 2008
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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00569751

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

Additional relevant MeSH terms:
Cardiovascular Diseases