Skip to main content
OpenTrials
Completed

NCT Number: NCT00371475

A Study of the TAXUS Liberté Stent for the Treatment of Long 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 38 mm stent to an historical TAXUS Express control. The control group is a case-matched, blended, long lesion subset 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 38 mm 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mercy Angiography Unit, 98 Mountain Road, First Floor, Auckland, Epsom, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General Inclusion Criteria:

  • Patient is at least 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 at least 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

Angiographic Inclusion Criteria:

  • 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.
  • Successful predilation is mandatory for entry into study
  • Target lesion located within a single native coronary artery
  • 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.
  • Cumulative target lesion length is greater than or equal to 26 mm and less than or equal to 34 mm (visual estimate)
  • Target lesion RVD is greater than or equal to 2.7 mm and less than or equal to 4.0 mm (visual estimate)
  • Target lesion diameter stenosis at least 50% (visual estimate)
  • Target lesion is de novo (i.e., a coronary lesion not previously treated)

General Exclusion Criteria:

  • Known hypersensitivity to paclitaxel
  • Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
  • 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 within 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
  • Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
  • Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
  • Male or female with known intention to procreate within 3 months after the index procedure
  • Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
  • Life expectancy of less than 24 months due to other medical condition
  • 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
  • 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:

  • Unprotected and protected left main coronary artery disease (patient with protected left main disease can be enrolled ONLY if the target lesion is in the RCA)
  • Target lesion is ostial in location (within 3.0 mm of vessel origin)
  • Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
  • Target lesion and/or target vessel proximal to the target lesion is tortuous
  • Target lesion is located within or distal to a >60 degree bend in the vessel
  • Target lesion involves a bifurcation with a side branch vessel >2.0mm in diameter
  • Target lesion is totally occluded (TIMI flow <1), either at baseline or predilation
  • Angiographic presence of probable or definite thrombus
  • Pre-treatment of the target vessel at the index procedure is not allowed with any device except for predilation with balloon angioplasty or cutting balloon.
  • A previously treated lesion within the target vessel:
  • <15mm from the target lesion (visual estimate)
  • Performed </= 6 months from index procedure
  • >30% residual stenosis after previous treatment

Treatment and study plan

TAXUS Liberté-SR

Device

Paclitaxel-Eluting Coronary 38 mm Stent

TAXUS™ Express

Device

Paclitaxel-Eluting Coronary Stent System

Primary outcomes

  1. Percent diameter stenosis of the analysis segment at 9-months

    Time frame: 9 Months

Secondary outcomes

  1. Clinical procedural and technical success

    Time frame: 5 Years

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

    Time frame: 9 Months

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

    Time frame: 5 Years

  4. Stent thrombosis rate

    Time frame: 5 Years

  5. Target Vessel Failure (TVF)

    Time frame: 5 Years

  6. Target Vessel Revascularization (TVR)

    Time frame: 5 Years

  7. QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)

    Time frame: 9 Months

  8. IVUS parameters (percent net volume obstruction, incomplete apposition, stent areas and volume, vessel areas and volume, lumen areas and volume, neointimal area volume)

    Time frame: 9 Months

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

TAXUS ATLAS LONG LESION: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With Long de Novo Coronary Artery Lesions

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Sep 4, 2006
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.