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| ID | Type | Description | Link |
|---|---|---|---|
| TAXUS ATLAS Direct Stent |
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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™ Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Other | Control data derived from ATLAS Workhorse Trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAXUS Liberté™-SR | Device | Paclitaxel-Eluting Coronary Stent System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis segment percent diameter stenosis at 9-months | 9 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints: Clinical procedural and technical success | 5 years | |
| Utilization parameters (equipment utilization, 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 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 diseased (>50% stenotic)branch vessel >2.0 mm in diameter
Target lesion is totally occluded (TIMI flow<1) at baseline
Angiographic presence of probable or definite thrombus
Pre-treatment of the target vessel at the index procedure is not allowed with any device
A previously treated lesion within the target vessel:
Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.
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| Name | Affiliation | Role |
|---|---|---|
| John A Ormiston, MD | Mercy Hospital | Principal Investigator |
| Mark A Turco, MD | Washington Adventist Hospital | Principal Investigator |
| Peter Maurer, MPH | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems | Little Rock | Arkansas | 72205 | United States | ||
| 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 Liberté™-SR |
| 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 |
| Target Vessel Revascularization (TVR) | 5 Years |
| QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss) | 9 Months |
| IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) | 9 Months |
| Mercy General Hospital |
| Sacramento |
| California |
| 95819 |
| United States |
| University of California San Diego Medical Center | San Diego | California | 92103-8784 | United States |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| St. Anthony's Medical Center | Rockford | Illinois | 61108 | 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 |
| 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 |
| Wake Medical Center | Raleigh | North Carolina | 27610 | 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 |
| Northwest Cardiovascular Research Institute | Spokane | Washington | 99204 | 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 |
| Shin Kong Memorial Hospital | Shih Lin Taipei | Taiwan |
| 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. |
| 19463293 | Derived | Ormiston JA, Mahmud E, Turco MA, Popma JJ, Weissman N, Cannon LA, Mann T, Lucca MJ, Lim ST, Hall JJ, McClean D, Dobies D, Mandinov L, Baim DS. Direct stenting with the TAXUS Liberte drug-eluting stent: results from the Taxus Atlas Direct Stent Study. JACC Cardiovasc Interv. 2008 Apr;1(2):150-60. doi: 10.1016/j.jcin.2008.01.003. |
| 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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