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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00371709
First received: August 31, 2006
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: TAXUS Liberté-SR
Device: TAXUS™ Express
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 9-Month Target Vessel Revascularization (TVR) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical procedural and technical success [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  • MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis rate [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Target Vessel Failure (TVF) [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • QCA parameters (binary restenosis rate, MLD and late loss) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  • IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

Enrollment: 871
Study Start Date: August 2004
Study Completion Date: March 2010
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Device: TAXUS Liberté-SR
Paclitaxel-Eluting Coronary Stent System
Arm 2
Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies
Device: TAXUS™ Express
Paclitaxel-Eluting Coronary Stent System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371709

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

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00371709     History of Changes
Other Study ID Numbers: S2013, TAXUS ATLAS
Study First Received: August 31, 2006
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014