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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00371423




Registration number
NCT00371423
Ethics application status
Date submitted
31/08/2006
Date registered
4/09/2006
Date last updated
2/02/2012

Titles & IDs
Public title
Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
Scientific title
A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Direct Stenting Treatment of Patients With de Novo Coronary Artery Lesions
Secondary ID [1] 0 0
TAXUS ATLAS Direct Stent
Secondary ID [2] 0 0
S2032
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 Liberté™-SR

Experimental: Arm 1 -

Other: Arm 2 - Control data derived from ATLAS Workhorse Trial


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

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

Outcomes
Primary outcome [1] 0 0
Analysis segment percent diameter stenosis at 9-months
Timepoint [1] 0 0
9 Months
Secondary outcome [1] 0 0
Secondary Endpoints: Clinical procedural and technical success
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Utilization parameters (equipment utilization, 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
Target Vessel Revascularization (TVR)
Timepoint [6] 0 0
5 Years
Secondary outcome [7] 0 0
QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)
Timepoint [7] 0 0
9 Months
Secondary outcome [8] 0 0
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume)
Timepoint [8] 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 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)

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. 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.

Angiographic

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.

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
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
247
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
New Zealand
State/province [16] 0 0
Epsom
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
New Zealand
State/province [18] 0 0
Christchurch
Country [19] 0 0
New Zealand
State/province [19] 0 0
Dunedin
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
Taiwan
State/province [21] 0 0
Shih Lin Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John A Ormiston, MD
Address 0 0
Mercy 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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00371423