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CompletedNCT00569751ARRIVE 2Updated Sep 29, 2008

TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

A Phase 4 interventional study of TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in Cardiovascular Disease and de Novo Coronary Lesions, sponsored by Boston Scientific Corporation. Completed at 53 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-29.

Sponsored by Boston Scientific Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
5,016
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Disease
  • de Novo Coronary Lesions

Keywords

  • de novo
  • coronary
  • coronary artery disease
  • coronary disease
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 5,016 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
5,016 participants (actual)

Interventions

  • DeviceTAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System

    Drug Eluting Stent used to treat de novo coronary artery lesions.

06

What researchers measure

Primary outcomes

  1. Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).

    Time frame: 1-year post-implant procedure

Secondary outcomes

  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

07

Study locations

53 sites
  • Scottsdale Healthcare
    Scottsdale, Arizona 85260, United States
  • Bakersfield Memorial Hospital
    Bakersfield, California 93301, United States
  • Desert Cardiology Consultants
    Rancho Mirage, California 92270, United States
  • Kaiser San Francisco
    San Francisco, California 94115, United States
  • Saint Vincent's Medical Center
    Jacksonville, Florida 32204, United States
  • Health First Clinical Research Institute
    Melbourne, Florida 32901, United States
  • Cardiology Consultants
    Pensacola, Florida 32504, United States
  • The Heart and Vascular Institute of Florida
    St. Petersburg, Florida 33705, United States
  • Idaho Cardiology Associates
    Boise, Idaho 83704, United States
  • Midwest Heart Foundation
    Lombard, Illinois 60148, United States
  • Heart Care Research Foundation
    Merrionette Park, Illinois 60803, United States
  • Advocate Christ Medical Center
    Oak Lawn, Illinois 60453, United States
  • Krannert Institute of Cardiology
    Indianapolis, Indiana 46202, United States
  • The Indiana Heart Hospital
    Indianapolis, Indiana 46250, United States
  • Community Hospital
    Munster, Indiana 46321, United States
  • Iowa Heart Center Research
    Des Moines, Iowa 50314, United States
  • University of Iowa Hospitals
    Iowa City, Iowa 52242, United States
  • University of Kansas Hospital
    Kansas City, Kansas 66160, United States
  • CHRISTUS St. Frances Cabrini Hospital
    Alexandria, Louisiana 71301, United States
  • Cardiovascular Research Foundation of Louisiana
    Baton Rouge, Louisiana 70808, United States
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
  • St. Vincent Hospital at Worcester Medical Center
    Worcester, Massachusetts 01608, United States
  • Thoracic & Cardiovascular Healthcare Foundation
    Lansing, Michigan 48912, United States
  • Great Lakes Heart and Vascular Institute
    St. Joseph, Michigan 49085, United States
  • Minnesota Heart and Vascular Center
    Edina, Minnesota 55435, United States
  • St. Paul Heart Clinic
    St. Paul, Minnesota 55102, United States
  • Barnes / Jewish (Washington University)
    St. Louis, Missouri 63110, United States
  • The Creighton Cardiac Center
    Omaha, Nebraska 68131, United States
  • Cardiovascular Associates of Delaware Valley
    Haddon Heights, New Jersey 08035, United States
  • Jersey Shore University Medical Center
    Neptune, New Jersey 07754, United States
  • New Mexico Heart Institute, PA
    Albuquerque, New Mexico 87102, United States
  • Saint Vincent's Catholic Medical Center of New York
    New York, New York 10011, United States
  • Mid-Carolina Cardiology Presbyterian Hospital
    Charlotte, North Carolina 28204, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Bethesda North Hospital
    Cincinnati, Ohio 45242, United States
  • HeartCare, Inc
    Columbus, Ohio 43215, United States
  • Parma Community General Hospital
    Parma, Ohio 44129, United States
  • St. Vincent Mercy Medical Center
    Toledo, Ohio 43608, United States
  • Heart Center of Tulsa
    Tulsa, Oklahoma 74114, United States
  • Albert Einstein Medical Center
    Philadelphia, Pennsylvania 19141, United States
  • The Western Pennsylvania Hospital
    Pittsburgh, Pennsylvania 15224, United States
  • Moffitt Heart and Vascular Group
    Wormleysburg, Pennsylvania 17043, United States
  • Main Line Health Center
    Wynnewood, Pennsylvania 19096, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29403, United States
  • Baptist Heart Institute
    Knoxville, Tennessee 37920, United States
  • St. Thomas Research Institute
    Nashville, Tennessee 37205, United States
  • Heart Center of North Texas
    Fort Worth, Texas 76104, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
  • Spectra Clinical Research Management Group
    McAllen, Texas 78504, United States
  • Sentara Norfolk General Hospital
    Norfolk, Virginia 23507, United States
  • North Cascade Cardiology, PLLC
    Bellingham, Washington 98225, United States
  • Cardiology Associates of Green Bay
    Green Bay, Wisconsin 54305-2425, United States
  • South Central Wisconsin Heart
    Madison, Wisconsin 53715, United States
08

References and documents

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. PubMed 20650436 ↗
  • 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. PubMed 20031730 ↗
  • 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. PubMed 19577985 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00569751
Lead sponsor
Boston Scientific Corporation
First posted
Dec 7, 2007
Start date
Oct 2004
Primary completion
Nov 2006
Completion
Jul 2008
Last update
Sep 29, 2008

Study contacts

Eileen Rose, MS
study director · Boston Scientific Corporation
John M Lasala, MD, PhD
principal investigator · Washington University School of Medicine
David A. Cox, MD
principal investigator · Lehigh Valley Physician Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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