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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: TAXUS Liberté-SR; Device: TAXUS™ Express

• Study Type: Interventional
• Enrollment (Actual): 871
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Cardiovascular Research Center Monash Medical Centre
    • Richmond, Victoria, Australia, 3121
      • Epworth Hospital
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L8
      • Vancouver General
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM Notre-Dame Hospital
• China
  • Kowloon, China
    • Queen Elizabeth Hospital
• New Zealand
  • Auckland, New Zealand, 1030
    • Auckland City Hospital
  • Christchurch, New Zealand
    • Christchurch Hospital
  • Dunedin, New Zealand
    • Dunedin Hospital
  • Epsom
    • Auckland, Epsom, New Zealand, 1003
      • Mercy Angiography Unit, 98 Mountain Road, First Floor
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 168752
    • National Heart Centre
• Taiwan
  • Shih Lin Taipei 111, Taiwan
    • Shin Kong Memorial Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taipei, Taiwan
    • Cathay General Hospital
  • Taipei 100, Taiwan
    • National Taiwan University Hospital
  • Taiwan, Taiwan, 83305
    • Chang-Gung Memorial Hospital, Kaohsiung
  • Tao-Yuan, Taiwan
    • Chang-Gung Memorial Hospital, Linkou
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Baptist Medical Center Princeton Cardiology PC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Beverly Hills, California, United States, 90210
      • Brotman Medical Center
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • Salinas, California, United States, 93901
      • Salinas Valley Memorial Healthcare System
    • San Diego, California, United States, 92103-8784
      • University of California San Diego Medical Center
    • Stockton, California, United States, 95204
      • St. Joseph's Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80012
      • The Medical Center of Aurora
  • Delaware
    • Newark, Delaware, United States, 19718-0002
      • Christiana Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Center
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Illinois
    • Rockford, Illinois, United States, 61108
      • Rockford Cardiology Associates
    • Springfield, Illinois, United States, 62701
      • Praire Cardiovascular Consultants, Ltd.
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • The Heart Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Willis Knighton Medical Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Mary's Duluth Clinic Regional Heart Center
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Cardiology
  • New York
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Elyria, Ohio, United States, 44035
      • North Ohio Research Elyria Memorial Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Foundation for Cardiovascular Research
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • The Pennsylvania State University Milton S Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of University of Pennsylvania
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Houston, Texas, United States, 77030-2767
      • Methodist DeBakey Heart Center
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Washington
    • Olympia, Washington, United States, 98506
      • St. Peter Hospital
    • Spokane, Washington, United States, 99204
      • Northwest Cardiovascular Research Institute-Spokane Cardiology
    • Spokane, Washington, United States, 99220
      • Sacred Heart Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St Lukes Medcial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Device: TAXUS Liberté-SR; Paclitaxel-Eluting Coronary Stent System
Other: Arm 2; Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies	Device: TAXUS™ Express; Paclitaxel-Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
9-Month Target Vessel Revascularization (TVR)	9 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
QCA parameters (binary restenosis rate, MLD and late loss)	9 Months
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset	9 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Peter Maurer, MPH, Boston Scientific Corporation; Principal Investigator: Mark A Turco, MD, Washington Adventist Hospital; Principal Investigator: John A Ormiston, MD, Mercy Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: August 31, 2006
• First Submitted That Met QC Criteria: September 1, 2006
• First Posted (Estimate): September 4, 2006

Study Record Updates

• Last Update Posted (Estimate): February 2, 2012
• Last Update Submitted That Met QC Criteria: February 1, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: S2013 (Other Identifier: CTEP); TAXUS ATLAS