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

NCT00371709 | Completed Phase 3 DMC

• 2 other identifiers: S2013TAXUS ATLAS
• Study Type: interventional
• Target: 871
• Locations: 7 countries
• Sites: 62

Brief 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. 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 9-Month Target Vessel Revascularization (TVR)

  9 Months

Secondary Outcomes (7)

• Clinical procedural and technical success

  5 Years

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

  9 Months

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

  5 Years

• Stent thrombosis rate

  5 Years

• Target Vessel Failure (TVF)

  5 Years

Study Arms (2)

Arm 1

EXPERIMENTAL

Device: TAXUS Liberté-SR

Arm 2

OTHER

Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies

Device: TAXUS™ Express

Interventions

TAXUS Liberté-SR DEVICE

Paclitaxel-Eluting Coronary Stent System

Arm 1

TAXUS™ Express DEVICE

Paclitaxel-Eluting Coronary Stent System

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥18 years old.
• Eligible for percutaneous coronary intervention (PCI)
• Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
• Left ventricular ejection fraction (LVEF) of \>/=25%
• Acceptable candidate for coronary artery bypass grafting (CABG)
• 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
• Willing to comply with all specified follow-up evaluations
• 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.
• 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.
• Target lesion located within a single native coronary artery
• Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
• RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
• Target lesion diameter stenosis ≥50% (visual estimate)
• Target lesion is de novo (i.e., a coronary lesion not previously treated)

You may not qualify if:

• Known hypersensitivity to paclitaxel
• Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
• 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
• Previous or planned treatment with intravascular brachytherapy in the target vessel
• Planned CABG ≤9-months post-index procedure
• 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.
• Cerebrovascular Accident (CVA) within the past 6 months
• Cardiogenic Shock
• Acute or chronic renal dysfunction
• Contraindication to ASA, or to both clopidogrel and ticlopidine
• Leukopenia
• Thrombocytopenia or thrombocytosis
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Known allergy to stainless steel
• Any prior true anaphylactic reaction to contrast agents

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (62)

Baptist Medical Center Princeton Cardiology PC

Birmingham, Alabama, 35211, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Brotman Medical Center

Beverly Hills, California, 90210, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Salinas Valley Memorial Healthcare System

Salinas, California, 93901, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103-8784, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Christiana Hospital

Newark, Delaware, 19718-0002, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Rockford Cardiology Associates

Rockford, Illinois, 61108, United States

Location

Praire Cardiovascular Consultants, Ltd.

Springfield, Illinois, 62701, United States

Location

The Heart Center

Indianapolis, Indiana, 46290, United States

Location

Willis Knighton Medical Center

Shreveport, Louisiana, 71103, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, 55805, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Dartmouth Hitchcock Cardiology

Lebanon, New Hampshire, 03756, United States

Location

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

North Ohio Research Elyria Memorial Hospital

Elyria, Ohio, 44035, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

The Pennsylvania State University Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Methodist DeBakey Heart Center

Houston, Texas, 77030-2767, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

St. Peter Hospital

Olympia, Washington, 98506, United States

Location

Northwest Cardiovascular Research Institute-Spokane Cardiology

Spokane, Washington, 99204, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99220, United States

Location

Aurora St Lukes Medcial Center

Milwaukee, Wisconsin, 53215, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Cardiovascular Research Center Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Epworth Hospital

Richmond, Victoria, 3121, Australia

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Vancouver General

Vancouver, British Columbia, V5Z 1L8, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

CHUM Notre-Dame Hospital

Montreal, Quebec, H2L 4M1, Canada

Location

Queen Elizabeth Hospital

Kowloon, China

Location

Mercy Angiography Unit, 98 Mountain Road, First Floor

Auckland, Epsom, 1003, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand, New Zealand

Location

Auckland City Hospital

Auckland, 1030, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Heart Centre

Singapore, 168752, Singapore

Location

Chang-Gung Memorial Hospital, Kaohsiung

Dawan, 83305, Taiwan

Location

Shin Kong Memorial Hospital

Shih Lin Taipei 111, Taiwan

Location

Cathay General Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Chang-Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 23232250 DERIVED

• 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.

  PMID: 19463432 DERIVED

• 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.

  PMID: 17448368 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mark A Turco, MD

  Washington Adventist Hospital

  PRINCIPAL INVESTIGATOR

• John A Ormiston, MD

  Mercy Hospital

  PRINCIPAL INVESTIGATOR

• Peter Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2006
• First Posted: September 4, 2006
• Study Start: August 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: March 1, 2010
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

CA (5); NZ (4); SG (2); TW (6); US (40); AU (4); CN (1)