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| Sponsor: | Boston Scientific Corporation |
|---|---|
| Information provided by: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00371475 |
Purpose
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.
| 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 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 |
| Enrollment: | 150 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | May 2011 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Device: TAXUS Liberté-SR
Paclitaxel-Eluting Coronary 38 mm Stent
|
|
Arm 2
Historical Comparator: control data derived from the TAXUS IV and TAXUS V clinical trials
|
Device: TAXUS™ Express
Paclitaxel-Eluting Coronary Stent System
|
Eligibility| 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:
A previously treated lesion within the target vessel:
Contacts and Locations
Show 25 Study Locations| Principal Investigator: | John A Ormiston, MD | Mercy Hospital |
| Principal Investigator: | Mark A Turco, MD | Washington Adventist Hospital |
| Study Director: | Eileen Rose, MS | Boston Scientific Corporation |
More Information
| Responsible Party: | Boston Scientific ( Peter Maurer ) |
| Study ID Numbers: | S2039, TAXUS ATLAS Long Lesion |
| Study First Received: | September 1, 2006 |
| Last Updated: | October 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00371475 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |