TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: TAXUS Liberté-SR Device: TAXUS™ Express |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 9-Month Target Vessel Revascularization (TVR) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
- Clinical procedural and technical success [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
- Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
- MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
- Stent thrombosis rate [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
- Target Vessel Failure (TVF) [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
- QCA parameters (binary restenosis rate, MLD and late loss) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 871 |
| Study Start Date: | August 2004 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Device: TAXUS Liberté-SR
Paclitaxel-Eluting Coronary Stent System
|
|
Arm 2
Historical Comparator: control data derived from the TAXUS IV and TAXUS V studies
|
Device: TAXUS™ Express
Paclitaxel-Eluting Coronary Stent System
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 62 Study Locations| Principal Investigator: | Mark A Turco, MD | Washington Adventist Hospital |
| Principal Investigator: | John A Ormiston, MD | Mercy Hospital |
| Study Director: | Peter Maurer, MPH | Boston Scientific Corporation |
More Information
No publications provided by Boston Scientific Corporation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00371709 History of Changes |
| Other Study ID Numbers: | S2013, TAXUS ATLAS |
| Study First Received: | August 31, 2006 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013