TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions
NCT ID: NCT00371709
Last Updated: 2012-02-02
Study Results
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Basic Information
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COMPLETED
PHASE3
871 participants
INTERVENTIONAL
2004-08-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
TAXUS Liberté-SR
Paclitaxel-Eluting Coronary Stent System
Arm 2
Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies
TAXUS™ Express
Paclitaxel-Eluting Coronary Stent System
Interventions
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TAXUS Liberté-SR
Paclitaxel-Eluting Coronary Stent System
TAXUS™ Express
Paclitaxel-Eluting Coronary Stent System
Eligibility Criteria
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Inclusion Criteria
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
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)
Exclusion Criteria
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.
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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark A Turco, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Adventist Hospital
John A Ormiston, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy Hospital
Peter Maurer, MPH
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Baptist Medical Center Princeton Cardiology PC
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Brotman Medical Center
Beverly Hills, California, United States
Mercy General Hospital
Sacramento, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
University of California San Diego Medical Center
San Diego, California, United States
St. Joseph's Medical Center
Stockton, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Christiana Hospital
Newark, Delaware, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Rockford Cardiology Associates
Rockford, Illinois, United States
Praire Cardiovascular Consultants, Ltd.
Springfield, Illinois, United States
The Heart Center
Indianapolis, Indiana, United States
Willis Knighton Medical Center
Shreveport, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Dartmouth Hitchcock Cardiology
Lebanon, New Hampshire, United States
New York Presbyterian Hospital
New York, New York, United States
WakeMed
Raleigh, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
North Ohio Research Elyria Memorial Hospital
Elyria, Ohio, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
The Pennsylvania State University Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Methodist DeBakey Heart Center
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
St. Peter Hospital
Olympia, Washington, United States
Northwest Cardiovascular Research Institute-Spokane Cardiology
Spokane, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Aurora St Lukes Medcial Center
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Cardiovascular Research Center Monash Medical Centre
Clayton, Victoria, Australia
Epworth Hospital
Richmond, Victoria, Australia
Foothills Medical Centre
Calgary, Alberta, Canada
Vancouver General
Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHUM Notre-Dame Hospital
Montreal, Quebec, Canada
Queen Elizabeth Hospital
Kowloon, , China
Mercy Angiography Unit, 98 Mountain Road, First Floor
Auckland, Epsom, New Zealand
Christchurch Hospital
Christchurch, New Zealand, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
National University Hospital
Singapore, , Singapore
National Heart Centre
Singapore, , Singapore
Chang-Gung Memorial Hospital, Kaohsiung
Dawan, , Taiwan
Shin Kong Memorial Hospital
Shih Lin Taipei 111, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang-Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Countries
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References
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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.
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.
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.
Other Identifiers
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TAXUS ATLAS
Identifier Type: -
Identifier Source: secondary_id
S2013
Identifier Type: -
Identifier Source: org_study_id
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