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| ID | Type | Description | Link |
|---|---|---|---|
| TAXUS ATLAS Small Vessel |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Other | 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 |
|
| Arm 3 | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAXUS Liberté-SR | Device | Paclitaxel-Eluting Coronary Stent, 2.25 mm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent diameter stenosis - analysis segment at 9 months | 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:
Unprotected and protected left main coronary artery disease (patient with protected left main disease can be enrolled ONLY if the target lesion is in the RCA)
Target lesion is ostial in location (within 3.0 mm of vessel origin)
Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
Target lesion and/or target vessel proximal to the target lesion is tortuous
Target lesion is located within or distal to a >60 degree bend in the vessel
Target lesion involves a bifurcation with a side branch vessel >1.5 mm (visual estimate)
Target lesion is totally occluded (TIMI flow <1), either at baseline or predilation
Angiographic presence of probable or definite thrombus
Pre-treatment of teh target vessel at the index procedure is not allowed with any device except for predilation with balloon angioplasty or cutting balloon
A previously treated lesion within the target vessel:
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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 |
|---|---|---|---|---|---|---|
| Mercy General Hospital | Sacramento | California | 95819 | United States | ||
| Christiana Hospital |
| 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. | |
| 20129555 |
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| TAXUS™ Express2 |
| Device |
Paclitaxel-Eluting Coronary Stent System |
|
| Express2 | Device | 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 |
| Target Vessel Revascularization (TVR) | 5 Years |
| QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss) | 9 months |
| Newark |
| Delaware |
| 19718-0002 |
| United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| St. John's Hospital | Springfield | Illinois | 62701 | United States |
| The Heart Center | Indianapolis | Indiana | 46290 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | 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 |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Wake Medical Center | Raleigh | North Carolina | 27610 | 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 |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| Methodist DeBakey Heart Center | Houston | Texas | 77030-2767 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Mercy Angiography Unit, 98 Mountain Road, First Floor | Auckland | Epsom | 1003 | New Zealand |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Christchurch Hospital | Christchurch | 8001 | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| National University Hospital | Singapore | 119074 | Singapore |
| National Heart Centre | Singapore | 168752 | Singapore |
| Derived |
| Doi H, Maehara A, Mintz GS, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Weissman NJ, Turco MA, Ormiston JA, Stone GW. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005. |
| 19463432 | 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. |
| 19463387 | Derived | Turco MA, Ormiston JA, Popma JJ, Hall JJ, Mann T, Cannon LA, Webster MW, Mishkel GJ, O'Shaughnessy CD, McGarry TF, Mandinov L, Dawkins KD, Baim DS. Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS Liberte stent: 1-year results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2008 Dec;1(6):699-709. doi: 10.1016/j.jcin.2008.09.007. |
| 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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