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Coronary Artery DiseasePhase 4ARRIVENCT00569491

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

A Phase 4 study testing TAXUS Express 2™ in people with Coronary Artery Disease, run by Boston Scientific Corporation at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
TAXUS Express 2™
Type of treatment
Medical device
How many people
2,585 participants
Where
50 sitesUnited States
Study dates
Feb 2004to Apr 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Asheville Cardiology Associates, PA

    Asheville, North Carolina, 28803

  • Northeast Cardiology Associates

    Bangor, Maine, 04401

  • Hope Heart Institute

    Bellevue, Washington, 98004

  • Aultman Hospital

    Canton, Ohio, 44710

  • Mid-Carolina Cardiology Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Metro Cardiology Consultants

    Coon Rapids, Minnesota, 55433

  • Methodist Dallas Medical Center

    Dallas, Texas, 75265

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Alexian Brothers Medical Center

    Elk Grove, Illinois, 60007

  • Cleveland Cardiovascular Research Foundation

    Fairview Park, Ohio, 44126

  • INOVA Fairfax Hospital

    Falls Church, Virginia, 22041

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Lutheran Hospital/NIRA

    Fort Wayne, Indiana, 46804

  • Advanced Cardiac Specialists

    Gilbert, Arizona, 85233

  • Regional Cardiology Associates

    Grand Blanc, Michigan, 48439

  • Pitt County Memorial Hospital

    Greenville, North Carolina, 27858

  • Greenville Hospital Systems

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • St Mary's Hospital

    Huntington, West Virginia, 25702

  • St Francis Hospital

    Indianapolis, Indiana, 46237

  • Cardiology Associates of NEA

    Jonesboro, Arkansas, 72401

  • Advanced Clinical Research Group, LLC

    Juniper, Florida, 33458

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Cardiovascular Associates, PC

    Kingsport, Tennessee, 37660

  • Our Lady of Lourdes

    Lafayette, Louisiana, 70503

  • Cardiovascular Consultants of Nevada

    Las Vegas, Nevada, 89109

  • Texas Cardiac Center

    Lubbock, Texas, 79410

  • Georgia Heart and Vascular Center

    Macon, Georgia, 31208

  • Morristown Memorial

    Morristown, New Jersey, 07079

  • St. Peters Hospital

    Olympia, Washington, 98506

  • Florida Heart Institute

    Orlando, Florida, 32803

  • Presbyterian University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Maine Medical Center

    Portland, Maine, 04102

  • WakeMed - Wake Heart Associates

    Raleigh, North Carolina, 27610

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Salinas Valley Memorial Hospital

    Salinas, California, 93901

  • Delmarva Heart Research Foundation, Inc

    Salisbury, Maryland, 21804

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78229

  • Good Samaritan

    San Jose, California, 95124

  • Willis Knighton Medical Center

    Shreveport, Louisiana, 71103

  • Avera Heart Hospital of South Dakota

    Sioux Falls, South Dakota, 57108

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Little Company of Mary Hospital

    Torrance, California, 90503

  • Trinity Mother Frances Hospital

    Tyler, Texas, 75702

  • Westchester County Medical Center

    Valhalla, New York, 10595

  • Care Foundation, Inc.

    Wausau, Wisconsin, 54401

  • Clear Lake Regional Medical Center

    Webster, Texas, 77598

Other trials in United States

About this study

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.

Being tested
TAXUS Express 2™
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAXUS Express 2™Device

    TAXUS Express™ Paclitaxel-Eluting Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year post-implant procedure

Secondary outcomes (3)

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

    Measured: 30 days, 6 months, 2 years post-implant procedure

  2. Rate of target vessel related cardiac events as classified by the Clinical Events Committee

    Measured: 30 days, 6 months, 1 and 2 years post-implant procedure

  3. Rate of other TAXUS related events

    Measured: 30 days, 6 months, 1 and 2 years post-implant procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2007 (estimated)
  2. Study startFeb 2004
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,585 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569491
Sponsor's protocol ID
S2021
Acronym
ARRIVE
Status last verified
Sep 2008
First submitted
6 Dec 2007
Last updated
25 Sep 2008
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TAXUS Express 2™ in people with Coronary Artery Disease, run by Boston Scientific Corporation at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee (time frame: 1 year post-implant procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569491, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2008.

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