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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00371423 |
TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberte Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: TAXUS Liberté™-SR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Single-Arm Study of the TAXUS Liberté™-SR Stent for the Direct Stenting Treatment of Patients With de Novo Coronary Artery Lesions |
Enrollment: | 247 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | October 2010 |
Primary Completion Date: | June 2006 (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
Control data derived from ATLAS Workhorse Trial
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Device: TAXUS Liberté™-SR
Paclitaxel-Eluting Coronary Stent System
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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:
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 |
Responsible Party: | Boston Scientific ( Peter Maurer ) |
Study ID Numbers: | S2032, TAXUS ATLAS Direct Stent |
Study First Received: | August 31, 2006 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00371423 History of Changes |
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 |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |