Loading clinical trials...

TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT00371709•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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 more criteria

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
+21 more criteria

Locations (62)

Baptist Medical Center Princeton Cardiology PC

Birmingham, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Brotman Medical Center

Beverly Hills, California, United States

Mercy General Hospital

Sacramento, California, United States

Salinas Valley Memorial Healthcare System

Salinas, California, United States

University of California San Diego Medical Center

San Diego, California, United States

St. Joseph's Medical Center

Stockton, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Christiana Hospital

Newark, Delaware, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

August 1, 2004

Primary Completion Date

November 1, 2005

Completion Date

March 1, 2010

Last Updated

February 2, 2012

Enrollment

871

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

TAXUS Liberté-SR

DEVICE

TAXUS™ Express

DEVICE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Coronary Artery Disease

View study

RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

Product Surveillance Registry

Essential Pro Study ( rEPIC04E-HK )

Factors Affect Outcomes in Cardiovascular Surgery