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| Sponsor: | Boston Scientific Corporation |
|---|---|
| Information provided by: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00371748 |
Purpose
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V patients treated with a 2.25 mm stent. The objective of the study is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: TAXUS Liberté-SR Device: TAXUS™ Express2 Device: Express2 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | TAXUS ATLAS SMALL VESSEL: A Multi-Center, Single-Arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels |
| Enrollment: | 261 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | April 2011 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Device: TAXUS Liberté-SR
Paclitaxel-Eluting Coronary Stent, 2.25 mm
|
|
Arm 2
Historical Comparator: control data derived from a TAXUS V de novo lesion and stent size-matched cohort randomized to receive a single, planned 2.25 mm DES
|
Device: TAXUS™ Express2
Paclitaxel-Eluting Coronary Stent System
|
|
Arm 3
Historical Comparator: control data derived from a TAXUS V de novo lesion size-matched cohort randomized to receive a 2.25 mm or 2.5 mm BMS
|
Device: Express2
Coronary Stent System
|
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients receiving the TAXUS Liberté-SR 2.25 mm paclitaxel-eluting stent. The results will be compared with two different historical control groups. The first control group consists of a subset of lesion-matched TAXUS V patients treated with a 2.25 mm TAXUS Express-SR paclitaxel-eluting stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the TAXUS Express-SR stent. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels. The second control group consists of a subset of lesion-matched TAXUS V patients treated with either a 2.5 mm or a 2.25 mm bare metal Express stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the Express bare metal stent. The hypothesis is that the TAXUS Liberté-SR stent has superior safety and efficacy to the Express bare metal stent in the treatment of de novo lesions in small coronary vessels.
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: | Mark A Turco, MD | Washington Adventist Hospital |
| Principal Investigator: | John A Ormiston, MD | Mercy Hospital |
| Study Director: | Eileen Rose, MS | Boston Scientific Corporation |
More Information
| Responsible Party: | Boston Scientific ( Peter Maurer ) |
| Study ID Numbers: | S2033, TAXUS ATLAS Small Vessel |
| Study First Received: | September 1, 2006 |
| Last Updated: | October 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00371748 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |