Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
NCT ID: NCT00371423
Last Updated: 2012-02-02
Study Results
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Basic Information
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COMPLETED
PHASE3
247 participants
INTERVENTIONAL
2005-03-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
TAXUS Liberté™-SR
Paclitaxel-Eluting Coronary Stent System
Arm 2
Control data derived from ATLAS Workhorse Trial
TAXUS Liberté™-SR
Paclitaxel-Eluting Coronary Stent System
Interventions
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TAXUS Liberté™-SR
Paclitaxel-Eluting Coronary Stent System
TAXUS Liberté™-SR
Paclitaxel-Eluting Coronary Stent System
Eligibility Criteria
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Inclusion Criteria
2. Eligible for percutaneous coronary intervention (PCI)
3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia, or documented silent ischemia
4. Left ventricular ejection fraction (LVEF) of ≥25%
5. Acceptable candidate for coronary artery bypass grafting (CABG)
6. Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
7. Willing to comply with all specified follow-up evaluations
1. Only one lesion appropriate for direct stenting (typically covered by one 24 mm stent or shorter), may be treated with the study stent. However, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or TAXUS Express stent.
2. Target lesion located within a single native coronary vessel
3. Target lesion enrolled for treatment may be composed of multiple lesions(not more than 10mm between diseased segments) but must be completely covered by one study stent.
4. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate) and is typically considered appropriate for direct stenting
5. RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
6. Target lesion diameter stenosis ≥50% (visual estimate)
7. Target lesion is de novo (i.e., a coronary lesion not previously treated)
Exclusion Criteria
2. Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
3. Previous or planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
4. Previous or planned treatment with intravascular brachytherapy in the target vessel
5. Planned CABG ≤9-months post-index procedure
6. MI within 72 hours prior to the index procedure and/or creatine kinase(CK) \>2x the local laboratory's ULN unless CK-MB is \<2x ULN.
7. Cerebrovascular Accident (CVA) within the past 6 months
8. Cardiogenic Shock
9. Acute or chronic renal dysfunction
10. Contraindication to ASA, or to both clopidogrel and ticlopidine
11. Patient is currently on warfarin or it is anticipated that treatment with warfarin will be required during any period within 6 months after the index procedure.
12. Leukopenia
13. Thrombocytopenia
14. Active peptic ulcer or active gastrointestinal (GI) bleeding
15. Known allergy to stainless steel
16. Any prior true anaphylactic reaction to contrast agents
17. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
18. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
19. Male or female with known intention to procreate within 3 months after the index procedure
20. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
21. Life expectancy of less than 24-months due to other medical condition
22. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
23. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
1. Unprotected left main coronary artery disease (patient with protected left main disease can be enrolled only if the target lesion is in the RCA)
2. Target lesion is ostial in location (within 3.0 mm of vessel origin)
3. Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
4. Target lesion and/or target vessel proximal to the target lesion is tortuous
5. Target lesion is located within or distal to a \>60 degree bend in the vessel
6. Target lesion involves a bifurcation with a diseased (\>50% stenotic)branch vessel \>2.0 mm in diameter
7. Target lesion is totally occluded (TIMI flow\<1) at baseline
8. Angiographic presence of probable or definite thrombus
9. Pre-treatment of the target vessel at the index procedure is not allowed with any device
10. A previously treated lesion within the target vessel:
* \<15 mm from the target lesion (visual estimate)
* Performed \</= 6 months from index procedure
* \>30% residual stenosis after previous treatment
11. Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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John A Ormiston, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy Hospital
Mark A Turco, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Adventist Hospital
Peter Maurer, MPH
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems
Little Rock, Arkansas, United States
Mercy General Hospital
Sacramento, California, United States
University of California San Diego Medical Center
San Diego, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Florida Hospital
Orlando, Florida, United States
St. Anthony's Medical Center
Rockford, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
The Heart Center
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
Wake Medical Center
Raleigh, North Carolina, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
The Pennsylvania State University Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Northwest Cardiovascular Research Institute
Spokane, Washington, United States
Mercy Angiography Unit, 98 Mountain Road, First Floor
Auckland, Epsom, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
National University Hospital
Singapore, , Singapore
National Heart Centre
Singapore, , Singapore
Shin Kong Memorial Hospital
Shih Lin Taipei, , Taiwan
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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TAXUS ATLAS Direct Stent
Identifier Type: -
Identifier Source: secondary_id
S2032
Identifier Type: -
Identifier Source: org_study_id
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