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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00371709




Registration number
NCT00371709
Ethics application status
Date submitted
31/08/2006
Date registered
4/09/2006
Date last updated
2/02/2012

Titles & IDs
Public title
TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions
Scientific 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
Secondary ID [1] 0 0
TAXUS ATLAS
Secondary ID [2] 0 0
S2013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TAXUS Liberté-SR
Treatment: Devices - TAXUS™ Express

Experimental: Arm 1 -

Other: Arm 2 - Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies


Treatment: Devices: TAXUS Liberté-SR
Paclitaxel-Eluting Coronary Stent System

Treatment: Devices: TAXUS™ Express
Paclitaxel-Eluting Coronary Stent System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
9-Month Target Vessel Revascularization (TVR)
Timepoint [1] 0 0
9 Months
Secondary outcome [1] 0 0
Clinical procedural and technical success
Timepoint [1] 0 0
5 Years
Secondary outcome [2] 0 0
Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)
Timepoint [2] 0 0
9 Months
Secondary outcome [3] 0 0
MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.
Timepoint [3] 0 0
5 Years
Secondary outcome [4] 0 0
Stent thrombosis rate
Timepoint [4] 0 0
5 Years
Secondary outcome [5] 0 0
Target Vessel Failure (TVF)
Timepoint [5] 0 0
5 Years
Secondary outcome [6] 0 0
QCA parameters (binary restenosis rate, MLD and late loss)
Timepoint [6] 0 0
9 Months
Secondary outcome [7] 0 0
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset
Timepoint [7] 0 0
9 Months

Eligibility
Key inclusion criteria
General

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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
871
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Cardiovascular Research Center Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arkansas
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California
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Colorado
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Delaware
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United States of America
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District of Columbia
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Florida
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United States of America
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Illinois
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Indiana
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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New Hampshire
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Washington
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United States of America
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Kowloon
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New Zealand
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Epsom
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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Singapore
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Singapore
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Taiwan
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Shih Lin Taipei 111
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Taiwan
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Taipei 100
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Taipei
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Taiwan
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Taiwan
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Taiwan
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Tao-Yuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00371709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark A Turco, MD
Address 0 0
Washington Adventist Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00371709