Clinical trial NCT00371709: TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions
Official title: TAXUS ATLAS: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 871
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: General Inclusion Criteria:

1. Patient is ≥18 years old.
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

Angiographic Inclusion Criteria:

1. Only one lesion (target lesion) 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 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.
3. Target lesion located within a single native coronary artery
4. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
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)

General Exclusion Criteria:

1. Known hypersensitivity to paclitaxel
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. Leukopenia
12. Thrombocytopenia or thrombocytosis
13. Active peptic ulcer or active gastrointestinal (GI) bleeding
14. Known allergy to stainless steel
15. Any prior true anaphylactic reaction to contrast agents
16. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
17. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
18. Male or female with known intention to procreate within 3 months after the index procedure
19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study.
20. Life expectancy of less than 24-months due to other medical condition
21. 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
22. 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.

Angiographic Exclusion Criteria:

1. Left main coronary artery disease (stenosis \>50%) whether protected or unprotected
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 side branch vessel \>2.0 mm in diameter.
7. Target lesion is totally occluded (TIMI flow \</= 1), either at baseline or predilation
8. Angiographic presence of probable or definite thrombus
9. Pre-treatment of the target vessel is not allowed with any device

Primary outcomes:
measure: 9-Month Target Vessel Revascularization (TVR)
timeFrame: 9 Months
Secondary outcomes:
measure: Clinical procedural and technical success
timeFrame: 5 Years
measure: Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)
timeFrame: 9 Months
measure: MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.
timeFrame: 5 Years
measure: Stent thrombosis rate
timeFrame: 5 Years
measure: Target Vessel Failure (TVF)
timeFrame: 5 Years
measure: QCA parameters (binary restenosis rate, MLD and late loss)
timeFrame: 9 Months
measure: IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset
timeFrame: 9 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton Cardiology PC
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Beverly Hills
country: United States
facility: Brotman Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Rockford
country: United States
facility: Rockford Cardiology Associates
state: Illinois
city: Springfield
country: United States
facility: Praire Cardiovascular Consultants, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: The Heart Center
state: Indiana
city: Shreveport
country: United States
facility: Willis Knighton Medical Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Cardiology
state: New Hampshire
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research Elyria Memorial Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Hershey
country: United States
facility: The Pennsylvania State University Milton S Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of University of Pennsylvania
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Houston
country: United States
facility: Methodist DeBakey Heart Center
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Olympia
country: United States
facility: St. Peter Hospital
state: Washington
city: Spokane
country: United States
facility: Northwest Cardiovascular Research Institute-Spokane Cardiology
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St Lukes Medcial Center
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Cardiovascular Research Center Monash Medical Centre
state: Victoria
city: Richmond
country: Australia
facility: Epworth Hospital
state: Victoria
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: CHUM Notre-Dame Hospital
state: Quebec
city: Kowloon
country: China
facility: Queen Elizabeth Hospital
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit, 98 Mountain Road, First Floor
state: Epsom
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Heart Centre
city: Shih Lin Taipei 111
country: Taiwan
facility: Shin Kong Memorial Hospital
city: Taipei 100
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taiwan
country: Taiwan
facility: Chang-Gung Memorial Hospital, Kaohsiung
city: Tao-Yuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou
Study officials:
affiliation: Washington Adventist Hospital
name: Mark A Turco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Hospital
name: John A Ormiston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Peter Maurer, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.