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

September 25, 2008 updated by: Boston Scientific Corporation
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5016

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).
Time Frame: 1-year post-implant procedure
1-year post-implant procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of other TAXUS related events
Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure
30 days, 6 months, 1 and 2 years post-implant procedure
Rate of TAXUS stent related cardiac events as classified by the CEC.
Time Frame: within 30 days, 6 months and 2 years
within 30 days, 6 months and 2 years
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
30 days, at 6 months, at 1 and 2 years post-implant procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2200 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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