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Cardiovascular DiseasePhase 4ARRIVE 2NCT00569751

TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

A Phase 4 study testing TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in people with Cardiovascular Disease and de Novo Coronary Lesions, run by Boston Scientific Corporation at 53 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 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
Type of treatment
Medical device
How many people
5,016 participants
Where
53 sitesUnited States
Study dates
Oct 2004to Jul 2008
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 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.

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • New Mexico Heart Institute, PA

    Albuquerque, New Mexico, 87102

  • CHRISTUS St. Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • Bakersfield Memorial Hospital

    Bakersfield, California, 93301

  • Cardiovascular Research Foundation of Louisiana

    Baton Rouge, Louisiana, 70808

  • North Cascade Cardiology, PLLC

    Bellingham, Washington, 98225

  • Idaho Cardiology Associates

    Boise, Idaho, 83704

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Mid-Carolina Cardiology Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • HeartCare, Inc

    Columbus, Ohio, 43215

  • Iowa Heart Center Research

    Des Moines, Iowa, 50314

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Minnesota Heart and Vascular Center

    Edina, Minnesota, 55435

  • Heart Center of North Texas

    Fort Worth, Texas, 76104

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Cardiology Associates of Green Bay

    Green Bay, Wisconsin, 54305-2425

  • Cardiovascular Associates of Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Krannert Institute of Cardiology

    Indianapolis, Indiana, 46202

  • The Indiana Heart Hospital

    Indianapolis, Indiana, 46250

  • University of Iowa Hospitals

    Iowa City, Iowa, 52242

  • Saint Vincent's Medical Center

    Jacksonville, Florida, 32204

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Baptist Heart Institute

    Knoxville, Tennessee, 37920

  • Thoracic & Cardiovascular Healthcare Foundation

    Lansing, Michigan, 48912

  • Midwest Heart Foundation

    Lombard, Illinois, 60148

  • South Central Wisconsin Heart

    Madison, Wisconsin, 53715

  • Spectra Clinical Research Management Group

    McAllen, Texas, 78504

  • Health First Clinical Research Institute

    Melbourne, Florida, 32901

  • Heart Care Research Foundation

    Merrionette Park, Illinois, 60803

  • Community Hospital

    Munster, Indiana, 46321

  • St. Thomas Research Institute

    Nashville, Tennessee, 37205

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • Saint Vincent's Catholic Medical Center of New York

    New York, New York, 10011

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • The Creighton Cardiac Center

    Omaha, Nebraska, 68131

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Cardiology Consultants

    Pensacola, Florida, 32504

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • The Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Desert Cardiology Consultants

    Rancho Mirage, California, 92270

  • Great Lakes Heart and Vascular Institute

    Saint Joseph, Michigan, 49085

  • St. Paul Heart Clinic

    Saint Paul, Minnesota, 55102

  • Kaiser San Francisco

    San Francisco, California, 94115

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85260

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Barnes / Jewish (Washington University)

    St Louis, Missouri, 63110

  • The Heart and Vascular Institute of Florida

    St. Petersburg, Florida, 33705

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Heart Center of Tulsa

    Tulsa, Oklahoma, 74114

  • St. Vincent Hospital at Worcester Medical Center

    Worcester, Massachusetts, 01608

  • Moffitt Heart and Vascular Group

    Wormleysburg, Pennsylvania, 17043

  • Main Line Health Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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.

Being tested
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
Keywords
de novo, coronary, coronary artery disease, coronary disease
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease

What participants receive

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

  • TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent SystemDevice

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

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 as classified by the Clinical Events Committee (CEC).

    Measured: 1-year post-implant procedure

Secondary outcomes (3)

  1. Rate of TAXUS stent related cardiac events as classified by the CEC.

    Measured: within 30 days, 6 months and 2 years

  2. Rate of target vessel related cardiac events as classified by the CEC.

    Measured: 30 days, at 6 months, at 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 startOct 2004
  3. Primary completionNov 2006
  4. Study completionJul 2008

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
5,016 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569751
Sponsor's protocol ID
S2200
Acronym
ARRIVE 2
Status last verified
Sep 2008
First submitted
6 Dec 2007
Last updated
29 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™ Express2™ Paclitaxel-Eluting Coronary Stent System in people with Cardiovascular Disease and de Novo Coronary Lesions, run by Boston Scientific Corporation at 53 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 29 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 53 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 as classified by the Clinical Events Committee (CEC). (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 NCT00569751, 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 29 Sep 2008.

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