Coronary Artery DiseasePhase 3NCT00371709
TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions
A Phase 3 study testing TAXUS Liberté-SR and TAXUS™ Express in people with Coronary Artery Disease, run by Boston Scientific Corporation at 62 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- TAXUS Liberté-SR and TAXUS™ Express
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 871 participants
- Where
- 62 sitesin 7 countries
- Study dates
- Aug 2004to Mar 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
- Patient is ≥18 years old.
- Eligible for percutaneous coronary intervention (PCI)
- Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
- Left ventricular ejection fraction (LVEF) of >/=25%
- Acceptable candidate for coronary artery bypass grafting (CABG)
- 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
- Willing to comply with all specified follow-up evaluations
Angiographic Inclusion Criteria:
- 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.
- 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.
- Target lesion located within a single native coronary artery
- Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
- RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
- Target lesion diameter stenosis ≥50% (visual estimate)
- Target lesion is de novo (i.e., a coronary lesion not previously treated)
General Exclusion Criteria:
- Known hypersensitivity to paclitaxel
- Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
- 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
- Previous or planned treatment with intravascular brachytherapy in the target vessel
- Planned CABG ≤9-months post-index procedure
- 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.
- Cerebrovascular Accident (CVA) within the past 6 months
- Cardiogenic Shock
- Acute or chronic renal dysfunction
- Contraindication to ASA, or to both clopidogrel and ticlopidine
- Leukopenia
- Thrombocytopenia or thrombocytosis
- Active peptic ulcer or active gastrointestinal (GI) bleeding
- Known allergy to stainless steel
- Any prior true anaphylactic reaction to contrast agents
- Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
- Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
- Male or female with known intention to procreate within 3 months after the index procedure
- 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.
- Life expectancy of less than 24-months due to other medical condition
- 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
- 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:
- Left main coronary artery disease (stenosis >50%) whether protected or unprotected
- 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 >2.0 mm in diameter.
- Target lesion is totally occluded (TIMI flow </= 1), either at baseline or predilation
- Angiographic presence of probable or definite thrombus
- Pre-treatment of the target vessel is not allowed with any device
Trial locations and contacts
62 sites in 7 countries.
62 sites in 7 countries
United States40 sites
The Medical Center of Aurora
Aurora, Colorado, 80012
Brotman Medical Center
Beverly Hills, California, 90210
Baptist Medical Center Princeton Cardiology PC
Birmingham, Alabama, 35211
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Riverside Methodist Hospital
Columbus, Ohio, 43214
Henry Ford Hospital
Detroit, Michigan, 48202
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805
North Ohio Research Elyria Memorial Hospital
Elyria, Ohio, 44035
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
The Pennsylvania State University Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Methodist DeBakey Heart Center
Houston, Texas, 77030-2767
The Heart Center
Indianapolis, Indiana, 46290
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Dartmouth Hitchcock Cardiology
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Aurora St Lukes Medcial Center
Milwaukee, Wisconsin, 53215
New York Presbyterian Hospital
New York, New York, 10021
Christiana Hospital
Newark, Delaware, 19718-0002
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
St. Peter Hospital
Olympia, Washington, 98506
Florida Hospital
Orlando, Florida, 32803
Northern Michigan Hospital
Petoskey, Michigan, 49770
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
WakeMed
Raleigh, North Carolina, 27610
Rockford Cardiology Associates
Rockford, Illinois, 61108
Mercy General Hospital
Sacramento, California, 95819
Salinas Valley Memorial Healthcare System
Salinas, California, 93901
University of California San Diego Medical Center
San Diego, California, 92103-8784
Willis Knighton Medical Center
Shreveport, Louisiana, 71103
Northwest Cardiovascular Research Institute-Spokane Cardiology
Spokane, Washington, 99204
Sacred Heart Medical Center
Spokane, Washington, 99220
Praire Cardiovascular Consultants, Ltd.
Springfield, Illinois, 62701
St. Joseph's Medical Center
Stockton, California, 95204
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Scott & White Memorial Hospital
Temple, Texas, 76508
North Mississippi Medical Center
Tupelo, Mississippi, 38801
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Taiwan6 sites
Chang-Gung Memorial Hospital, Kaohsiung
Dawan, 83305
Shin Kong Memorial Hospital
Shih Lin Taipei 111
Cathay General Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang-Gung Memorial Hospital, Linkou
Taoyuan
Canada5 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
CHUM Notre-Dame Hospital
Montreal, Quebec, H2L 4M1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Vancouver General
Vancouver, British Columbia, V5Z 1L8
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Box Hill Hospital
Box Hill, Victoria, 3128
Cardiovascular Research Center Monash Medical Centre
Clayton, Victoria, 3168
Epworth Hospital
Richmond, Victoria, 3121
New Zealand4 sites
Mercy Angiography Unit, 98 Mountain Road, First Floor
Auckland, Epsom, 1003
Auckland City Hospital
Auckland, 1030
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin
Singapore2 sites
National University Hospital
Singapore, 119074
National Heart Centre
Singapore, 168752
About this study
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
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.
- Conditions
- Coronary Artery Disease
- Being tested
- TAXUS Liberté-SR, TAXUS™ Express
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAXUS Liberté-SRDevice
Paclitaxel-Eluting Coronary Stent System
TAXUS™ ExpressDevice
Paclitaxel-Eluting Coronary Stent System
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Device: TAXUS Liberté-SR |
| Arm 2 | Other | Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies Receives: Device: TAXUS™ Express |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-Month Target Vessel Revascularization (TVR)
Measured: 9 Months
Secondary outcomes (7)
Clinical procedural and technical success
Measured: 5 Years
Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)
Measured: 9 Months
MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.
Measured: 5 Years
Stent thrombosis rate
Measured: 5 Years
Target Vessel Failure (TVF)
Measured: 5 Years
QCA parameters (binary restenosis rate, MLD and late loss)
Measured: 9 Months
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startAug 2004
- Primary completionNov 2005
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Turco, MD, Principal investigator, Washington Adventist HospitalJohn A Ormiston, MD, Principal investigator, Mercy HospitalPeter Maurer, MPH, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371709
- Sponsor's protocol ID
- S2013
- Other IDs
- TAXUS ATLAS
- Status last verified
- Feb 2012
- First submitted
- 31 Aug 2006
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23232250Mahmud 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.
PubMed 19463432Turco 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.
PubMed 17448368
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00371709
- Acronym / sponsor ID
- S2013
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: TAXUS Liberté-SR |
| Arm 2 | Other | Device: TAXUS™ ExpressHistorical Comparator: control data derived from the TAXUS IV and TAXUS V studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAXUS Liberté-SRPaclitaxel-Eluting Coronary Stent System | Device | Arm 1 |
| TAXUS™ ExpressPaclitaxel-Eluting Coronary Stent System | Device | Arm 2 |
Primary outcome
9-Month Target Vessel Revascularization (TVR)
Time frame: 9 Months
7 secondary outcomes
Clinical procedural and technical success
Time frame: 5 Years
Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)
Time frame: 9 Months
MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.
Time frame: 5 Years
Stent thrombosis rate
Time frame: 5 Years
Target Vessel Failure (TVF)
Time frame: 5 Years
QCA parameters (binary restenosis rate, MLD and late loss)
Time frame: 9 Months
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset
Time frame: 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- Derived from this study: PubMed 23232250Ormiston 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.
- Derived from this study: PubMed 19463432Mahmud 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.
- Derived from this study: PubMed 17448368Turco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Turco, MD principal investigator
Washington Adventist Hospital
John A Ormiston, MD principal investigator
Mercy Hospital
Peter Maurer, MPH study director
Boston Scientific Corporation
62 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAXUS Liberté-SR and TAXUS™ Express in people with Coronary Artery Disease, run by Boston Scientific Corporation at 62 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Taiwan, Canada, Australia, New Zealand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-Month Target Vessel Revascularization (TVR) (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371709, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.