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

August 31, 2006
February 1, 2012
August 2004
November 2005   (final data collection date for primary outcome measure)
9-Month Target Vessel Revascularization (TVR) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
9-Month Target Vessel Revascularization (TVR)
Complete list of historical versions of study NCT00371709 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinical procedural and technical success
  • Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)
  • MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.
  • Stent thrombosis rate
  • Target Vessel Failure (TVF)
  • QCA parameters (binary restenosis rate, MLD and late loss)
  • IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: TAXUS Liberté-SR
    Paclitaxel-Eluting Coronary Stent System
  • Device: TAXUS™ Express
    Paclitaxel-Eluting Coronary Stent System
  • Experimental: Arm 1
    Intervention: Device: TAXUS Liberté-SR
  • Arm 2
    Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies
    Intervention: Device: TAXUS™ Express

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
871
March 2010
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   China,   New Zealand,   Singapore,   Taiwan
 
NCT00371709
S2013, TAXUS ATLAS
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
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
Boston Scientific Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP