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Coronary Artery DiseasePhase 3NCT00371709

TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions

A Phase 3 study testing TAXUS Liberté-SR and TAXUS™ Express in people with Coronary Artery Disease, run by Boston Scientific Corporation at 62 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control. The control group is a case-matched, blended population of TAXUS Express patients from the TAXUS IV and TAXUS V de novo clinical trials. 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 Liberté-SR and TAXUS™ Express
Could I receive a placebo?
No, everyone receives an active treatment
How many people
871 participants
Where
62 sitesin 7 countries
Study dates
Aug 2004to Mar 2010
Phase
Phase 3
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

General Inclusion Criteria:

  1. Patient is ≥18 years old.
  2. Eligible for percutaneous coronary intervention (PCI)
  3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
  4. Left ventricular ejection fraction (LVEF) of >/=25%
  5. Acceptable candidate for coronary artery bypass grafting (CABG)
  6. Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  7. Willing to comply with all specified follow-up evaluations

Angiographic Inclusion Criteria:

  1. Only one lesion (target lesion) may be treated with the study stent. However, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or TAXUS Express stent.
  2. Target lesion enrolled for treatment may be composed of multiple lesions (not more than 10mm between diseased segments)but must be completely covered by one study stent.
  3. Target lesion located within a single native coronary artery
  4. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
  5. RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
  6. Target lesion diameter stenosis ≥50% (visual estimate)
  7. Target lesion is de novo (i.e., a coronary lesion not previously treated)

General Exclusion Criteria:

  1. Known hypersensitivity to paclitaxel
  2. Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
  3. Previous or planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
  4. Previous or planned treatment with intravascular brachytherapy in the target vessel
  5. Planned CABG ≤9-months post-index procedure
  6. MI within 72 hours prior to the index procedure and or creatine kinase(CK) >2x the local laboratory's ULN unless CK-MB is <2x ULN.
  7. Cerebrovascular Accident (CVA) within the past 6 months
  8. Cardiogenic Shock
  9. Acute or chronic renal dysfunction
  10. Contraindication to ASA, or to both clopidogrel and ticlopidine
  11. Leukopenia
  12. Thrombocytopenia or thrombocytosis
  13. Active peptic ulcer or active gastrointestinal (GI) bleeding
  14. Known allergy to stainless steel
  15. Any prior true anaphylactic reaction to contrast agents
  16. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
  17. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
  18. Male or female with known intention to procreate within 3 months after the index procedure
  19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study.
  20. Life expectancy of less than 24-months due to other medical condition
  21. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  22. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Angiographic Exclusion Criteria:

  1. Left main coronary artery disease (stenosis >50%) whether protected or unprotected
  2. Target lesion is ostial in location (within 3.0 mm of vessel origin)
  3. Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate.
  4. Target lesion and/or target vessel proximal to the target lesion is tortuous.
  5. Target lesion is located within or distal to a >60 degree bend in the vessel
  6. Target lesion involves a bifurcation with a side branch vessel >2.0 mm in diameter.
  7. Target lesion is totally occluded (TIMI flow </= 1), either at baseline or predilation
  8. Angiographic presence of probable or definite thrombus
  9. Pre-treatment of the target vessel is not allowed with any device

Trial locations and contacts

62 sites in 7 countries.

62 sites in 7 countries

United States40 sites
  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Brotman Medical Center

    Beverly Hills, California, 90210

  • Baptist Medical Center Princeton Cardiology PC

    Birmingham, Alabama, 35211

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. Mary's Duluth Clinic Regional Heart Center

    Duluth, Minnesota, 55805

  • North Ohio Research Elyria Memorial Hospital

    Elyria, Ohio, 44035

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • The Pennsylvania State University Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Methodist DeBakey Heart Center

    Houston, Texas, 77030-2767

  • The Heart Center

    Indianapolis, Indiana, 46290

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Dartmouth Hitchcock Cardiology

    Lebanon, New Hampshire, 03756

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • Aurora St Lukes Medcial Center

    Milwaukee, Wisconsin, 53215

  • New York Presbyterian Hospital

    New York, New York, 10021

  • Christiana Hospital

    Newark, Delaware, 19718-0002

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73120

  • St. Peter Hospital

    Olympia, Washington, 98506

  • Florida Hospital

    Orlando, Florida, 32803

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Hospital of University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Maine Medical Center

    Portland, Maine, 04102

  • WakeMed

    Raleigh, North Carolina, 27610

  • Rockford Cardiology Associates

    Rockford, Illinois, 61108

  • Mercy General Hospital

    Sacramento, California, 95819

  • Salinas Valley Memorial Healthcare System

    Salinas, California, 93901

  • University of California San Diego Medical Center

    San Diego, California, 92103-8784

  • Willis Knighton Medical Center

    Shreveport, Louisiana, 71103

  • Northwest Cardiovascular Research Institute-Spokane Cardiology

    Spokane, Washington, 99204

  • Sacred Heart Medical Center

    Spokane, Washington, 99220

  • Praire Cardiovascular Consultants, Ltd.

    Springfield, Illinois, 62701

  • St. Joseph's Medical Center

    Stockton, California, 95204

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

Other trials in United States

Taiwan6 sites
  • Chang-Gung Memorial Hospital, Kaohsiung

    Dawan, 83305

  • Shin Kong Memorial Hospital

    Shih Lin Taipei 111

  • Cathay General Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Chang-Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

Canada5 sites
  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • CHUM Notre-Dame Hospital

    Montreal, Quebec, H2L 4M1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Vancouver General

    Vancouver, British Columbia, V5Z 1L8

Other trials in Canada

Australia4 sites
  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Cardiovascular Research Center Monash Medical Centre

    Clayton, Victoria, 3168

  • Epworth Hospital

    Richmond, Victoria, 3121

Other trials in Australia

New Zealand4 sites
  • Mercy Angiography Unit, 98 Mountain Road, First Floor

    Auckland, Epsom, 1003

  • Auckland City Hospital

    Auckland, 1030

  • Christchurch Hospital

    Christchurch, New Zealand

  • Dunedin Hospital

    Dunedin

Other trials in New Zealand

Singapore2 sites
  • National University Hospital

    Singapore, 119074

  • National Heart Centre

    Singapore, 168752

Other trials in Singapore

China1 site
  • Queen Elizabeth Hospital

    Kowloon

Other trials in China

About this study

Official title: TAXUS ATLAS: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control. The control group is a case-matched, blended population of TAXUS Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate clinical outcomes of TAXUS Liberté-SR stent in de novo lesions and to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.

Being tested
TAXUS Liberté-SR, TAXUS™ Express
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 Liberté-SRDevice

    Paclitaxel-Eluting Coronary Stent System

  • TAXUS™ ExpressDevice

    Paclitaxel-Eluting Coronary Stent System

Study groups in NCT00371709
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Device: TAXUS Liberté-SR
Arm 2OtherHistorical Comparator: control data derived from the TAXUS IV and TAXUS V studies
Receives: Device: TAXUS™ Express

What is being measured

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

  1. 9-Month Target Vessel Revascularization (TVR)

    Measured: 9 Months

Secondary outcomes (7)
  1. Clinical procedural and technical success

    Measured: 5 Years

  2. Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)

    Measured: 9 Months

  3. MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.

    Measured: 5 Years

  4. Stent thrombosis rate

    Measured: 5 Years

  5. Target Vessel Failure (TVF)

    Measured: 5 Years

  6. QCA parameters (binary restenosis rate, MLD and late loss)

    Measured: 9 Months

  7. IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset

    Measured: 9 Months

Timeline

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

  1. First posted4 Sep 2006 (estimated)
  2. Study startAug 2004
  3. Primary completionNov 2005
  4. Study completionMar 2010

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
871 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00371709
Sponsor's protocol ID
S2013
Other IDs
TAXUS ATLAS
Status last verified
Feb 2012
First submitted
31 Aug 2006
Last updated
2 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Ormiston JA, Charles O, Mann T, Hall JJ, McGarry T, Cannon LA, Webster MW, Mishkel GJ, Underwood PL, Dawkins KD. Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberte paclitaxel-eluting stent in de-novo coronary artery lesions. Coron Artery Dis. 2013 Jan;24(1):61-8. doi: 10.1097/MCA.0b013e32835b3932.

    PubMed 23232250
  • Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberte attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2009 Mar;2(3):240-52. doi: 10.1016/j.jcin.2008.12.009.

    PubMed 19463432
  • Turco MA, Ormiston JA, Popma JJ, Mandinov L, O'Shaughnessy CD, Mann T, McGarry TF, Wu CJ, Chan C, Webster MW, Hall JJ, Mishkel GJ, Cannon LA, Baim DS, Koglin J. Polymer-based, paclitaxel-eluting TAXUS Liberte stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83. doi: 10.1016/j.jacc.2007.01.069. Epub 2007 Apr 6.

    PubMed 17448368

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAXUS Liberté-SR and TAXUS™ Express in people with Coronary Artery Disease, run by Boston Scientific Corporation at 62 sites in 7 countries.

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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Taiwan, Canada, Australia, New Zealand and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

9-Month Target Vessel Revascularization (TVR) (time frame: 9 Months). 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 NCT00371709, 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 2 Feb 2012.

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