Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

Study Overview
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Brief Summary
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TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: TAXUS Liberté™-SR
* Device: TAXUS Liberté™-SR


Participation Criteria
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Eligibility Criteria
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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 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. Target lesion located within a single native coronary vessel 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. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate) and is typically considered appropriate for direct stenting 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 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. Leukopenia Thrombocytopenia 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 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: Unprotected left main coronary artery disease (patient with protected left main disease can be enrolled only if the target lesion is in the RCA) 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 diseased (>50% stenotic)branch vessel >2.0 mm in diameter Target lesion is totally occluded (TIMI flow<1) at baseline Angiographic presence of probable or definite thrombus Pre-treatment of the target vessel at the index procedure is not allowed with any device 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 Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Device: TAXUS Liberté™-SR<br>* Paclitaxel-Eluting Coronary Stent System<br>|
| Other: Arm 2<br>Control data derived from ATLAS Workhorse Trial | Device: TAXUS Liberté™-SR<br>* Paclitaxel-Eluting Coronary Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis segment percent diameter stenosis at 9-months |  | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints: Clinical procedural and technical success |  | 5 years | 
| Utilization parameters (equipment utilization, 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 | 
| Target Vessel Revascularization (TVR) |  | 5 Years | 
| QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss) |  | 9 Months | 
| IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) |  | 9 Months |