Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00371423
First received: August 31, 2006
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation


Condition Intervention Phase
Coronary Artery Disease
Device: TAXUS Liberté™-SR
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: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Direct Stenting 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:
  • Analysis segment percent diameter stenosis at 9-months [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Endpoints: Clinical procedural and technical success [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Utilization parameters (equipment utilization, 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 ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • QCA parameters (binary restenosis rate, in-stent %DS, 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) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

Enrollment: 247
Study Start Date: March 2005
Study Completion Date: September 2010
Primary Completion Date: June 2006 (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
Control data derived from ATLAS Workhorse Trial
Device: TAXUS Liberté™-SR
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 appropriate for direct stenting (typically covered by one 24 mm stent or shorter), 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 located within a single native coronary vessel
  3. 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.
  4. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate) and is typically considered appropriate for direct stenting
  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. Patient is currently on warfarin or it is anticipated that treatment with warfarin will be required during any period within 6 months after the index procedure.
  12. Leukopenia
  13. Thrombocytopenia
  14. Active peptic ulcer or active gastrointestinal (GI) bleeding
  15. Known allergy to stainless steel
  16. Any prior true anaphylactic reaction to contrast agents
  17. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
  18. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
  19. Male or female with known intention to procreate within 3 months after the index procedure
  20. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
  21. Life expectancy of less than 24-months due to other medical condition
  22. 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
  23. 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. Unprotected left main coronary artery disease (patient with protected left main disease can be enrolled only if the target lesion is in the RCA)
  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 diseased (>50% stenotic)branch vessel >2.0 mm in diameter
  7. Target lesion is totally occluded (TIMI flow<1) at baseline
  8. Angiographic presence of probable or definite thrombus
  9. Pre-treatment of the target vessel at the index procedure is not allowed with any device
  10. A previously treated lesion within the target vessel:

    • <15 mm from the target lesion (visual estimate)
    • Performed </= 6 months from index procedure
    • >30% residual stenosis after previous treatment
  11. Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.
  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: NCT00371423

  Show 25 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: John A Ormiston, MD Mercy Hospital
Principal Investigator: Mark A Turco, MD Washington Adventist 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: NCT00371423     History of Changes
Other Study ID Numbers: S2032, TAXUS ATLAS Direct Stent
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 August 20, 2014