|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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
Hide Study Locations| United States, California | |
| Mercy General Hospital | |
| Sacramento, California, United States, 95819 | |
| United States, Delaware | |
| Christiana Hospital | |
| Newark, Delaware, United States, 19718-0002 | |
| United States, Florida | |
| Florida Hospital | |
| Orlando, Florida, United States, 32803 | |
| United States, Illinois | |
| St. John's Hospital | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| The Heart Center | |
| Indianapolis, Indiana, United States, 46290 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Washington Adventist Hospital | |
| Takoma Park, Maryland, United States, 20912 | |
| United States, Michigan | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| United States, Minnesota | |
| St. Mary's Duluth Clinic Regional Heart Center | |
| Duluth, Minnesota, United States, 55805 | |
| United States, Mississippi | |
| North Mississippi Medical Center | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Wake Medical Center | |
| Raleigh, North Carolina, United States, 27610 | |
| United States, Ohio | |
| North Ohio Research Elyria Memorial Hospital | |
| Elyria, Ohio, United States, 44035 | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| United States, Oklahoma | |
| Oklahoma Foundation for Cardiovascular Research | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Pennsylvania | |
| The Pennsylvania State University Milton S Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Tennessee | |
| Wellmont Holston Valley Medical Center | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Methodist DeBakey Heart Center | |
| Houston, Texas, United States, 77030-2767 | |
| Scott & White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| New Zealand | |
| Auckland City Hospital | |
| Auckland, New Zealand, 1023 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 8001 | |
| Dunedin Hospital | |
| Dunedin, New Zealand | |
| New Zealand, Epsom | |
| Mercy Angiography Unit, 98 Mountain Road, First Floor | |
| Auckland, Epsom, New Zealand, 1003 | |
| Singapore | |
| National Heart Centre | |
| Singapore, Singapore, 168752 | |
| National University Hospital | |
| Singapore, Singapore | |
| 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 |