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| ID | Type | Description | Link |
|---|---|---|---|
| TAXUS ATLAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Other | Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAXUS Liberté-SR | Device | Paclitaxel-Eluting Coronary Stent System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 9-Month Target Vessel Revascularization (TVR) | 9 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical procedural and technical success | 5 Years | |
| Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used) | 9 Months |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Turco, MD | Washington Adventist Hospital | Principal Investigator |
| John A Ormiston, MD | Mercy Hospital | Principal Investigator |
| Peter Maurer, MPH | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center Princeton Cardiology PC | Birmingham | Alabama | 35211 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23232250 | Derived | Ormiston JA, Charles O, Mann T, Hall JJ, McGarry T, Cannon LA, Webster MW, Mishkel GJ, Underwood PL, Dawkins KD. Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberte paclitaxel-eluting stent in de-novo coronary artery lesions. Coron Artery Dis. 2013 Jan;24(1):61-8. doi: 10.1097/MCA.0b013e32835b3932. | |
| 19463432 |
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| TAXUSâ„¢ Express |
| Device |
Paclitaxel-Eluting Coronary Stent System |
|
| MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure. | 5 Years |
| Stent thrombosis rate | 5 Years |
| Target Vessel Failure (TVF) | 5 Years |
| QCA parameters (binary restenosis rate, MLD and late loss) | 9 Months |
| IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset | 9 Months |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Brotman Medical Center | Beverly Hills | California | 90210 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Salinas Valley Memorial Healthcare System | Salinas | California | 93901 | United States |
| University of California San Diego Medical Center | San Diego | California | 92103-8784 | United States |
| St. Joseph's Medical Center | Stockton | California | 95204 | United States |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | United States |
| Christiana Hospital | Newark | Delaware | 19718-0002 | United States |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Rockford Cardiology Associates | Rockford | Illinois | 61108 | United States |
| Praire Cardiovascular Consultants, Ltd. | Springfield | Illinois | 62701 | United States |
| The Heart Center | Indianapolis | Indiana | 46290 | United States |
| Willis Knighton Medical Center | Shreveport | Louisiana | 71103 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| St. Mary's Duluth Clinic Regional Heart Center | Duluth | Minnesota | 55805 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Dartmouth Hitchcock Cardiology | Lebanon | New Hampshire | 03756 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| WakeMed | Raleigh | North Carolina | 27610 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| North Ohio Research Elyria Memorial Hospital | Elyria | Ohio | 44035 | United States |
| Oklahoma Foundation for Cardiovascular Research | Oklahoma City | Oklahoma | 73120 | United States |
| The Pennsylvania State University Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Methodist DeBakey Heart Center | Houston | Texas | 77030-2767 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| St. Peter Hospital | Olympia | Washington | 98506 | United States |
| Northwest Cardiovascular Research Institute-Spokane Cardiology | Spokane | Washington | 99204 | United States |
| Sacred Heart Medical Center | Spokane | Washington | 99220 | United States |
| Aurora St Lukes Medcial Center | Milwaukee | Wisconsin | 53215 | United States |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Cardiovascular Research Center Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Epworth Hospital | Richmond | Victoria | 3121 | Australia |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Vancouver General | Vancouver | British Columbia | V5Z 1L8 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| CHUM Notre-Dame Hospital | Montreal | Quebec | H2L 4M1 | Canada |
| Queen Elizabeth Hospital | Kowloon | China |
| Mercy Angiography Unit, 98 Mountain Road, First Floor | Auckland | Epsom | 1003 | New Zealand |
| Christchurch Hospital | Christchurch | New Zealand | New Zealand |
| Auckland City Hospital | Auckland | 1030 | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| National University Hospital | Singapore | 119074 | Singapore |
| National Heart Centre | Singapore | 168752 | Singapore |
| Chang-Gung Memorial Hospital, Kaohsiung | Dawan | 83305 | Taiwan |
| Shin Kong Memorial Hospital | Shih Lin Taipei 111 | Taiwan |
| Cathay General Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Chang-Gung Memorial Hospital, Linkou | Taoyuan | Taiwan |
| Derived |
| Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberte attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2009 Mar;2(3):240-52. doi: 10.1016/j.jcin.2008.12.009. |
| 17448368 | Derived | Turco MA, Ormiston JA, Popma JJ, Mandinov L, O'Shaughnessy CD, Mann T, McGarry TF, Wu CJ, Chan C, Webster MW, Hall JJ, Mishkel GJ, Cannon LA, Baim DS, Koglin J. Polymer-based, paclitaxel-eluting TAXUS Liberte stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83. doi: 10.1016/j.jacc.2007.01.069. Epub 2007 Apr 6. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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