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Sponsored by: |
Boston Scientific Corporation |
---|---|
Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00371709 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 871 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | March 2010 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
General Inclusion Criteria:
Angiographic Inclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
Principal Investigator: | Mark A Turco, MD | Washington Adventist Hospital |
Principal Investigator: | John A Ormiston, MD | Mercy Hospital |
Study Director: | Eileen Rose, MS | Boston Scientific Corporation |
Responsible Party: | Boston Scientific ( Peter Maurer ) |
Study ID Numbers: | S2013, TAXUS ATLAS |
Study First Received: | August 31, 2006 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00371709 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |