TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: TAXUS Liberté-SR; Device: TAXUS™ Express

• Registration Number: NCT00371709
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-11
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Study Completion: 2010-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 871

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	TAXUS Liberté-SR	-
Arm 2	TAXUS™ Express	Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies

Primary Outcome Measures

Name	Time	Method
9-Month Target Vessel Revascularization (TVR)	9 Months

Secondary Outcome Measures

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

Trial Locations

Locations (62)

Baptist Medical Center Princeton Cardiology PC; 🇺🇸 Birmingham, Alabama, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Brotman Medical Center; 🇺🇸 Beverly Hills, California, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

Salinas Valley Memorial Healthcare System; 🇺🇸 Salinas, California, United States

University of California San Diego Medical Center; 🇺🇸 San Diego, California, United States

St. Joseph's Medical Center; 🇺🇸 Stockton, California, United States

The Medical Center of Aurora; 🇺🇸 Aurora, Colorado, United States

Christiana Hospital; 🇺🇸 Newark, Delaware, United States

George Washington University Medical Center; 🇺🇸 Washington, District of Columbia, United States

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