TAXUS PERSEUS Workhorse

Study Overview
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Brief Summary
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The purpose of the TAXUS PERSEUS Workhorse trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries of 2.75 mm to 4.0 mm diameter.

Detailed Description
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This is a prospective, 3:1 randomization, multi-center trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries ≥ 2.75 mm and ≤ 4.0 mm in diameter, compared to a control group of TAXUS Express2 Paclitaxel-Eluting Coronary Stent System . One thousand two hundred sixty-four (1264) subjects will be treated with either the TAXUS® Element™ stent or the TAXUS® Express2 ™stent at a maximum of 100 clinical sites. Randomization to treatment group will be unbalanced 3:1 towards the test group to gain maximum clinical experience with the new TAXUS® Element™ platform. Follow-up at 30 days, 9 months and 12 months will be completed in all subjects enrolled in the study. Angiographic follow-up at 9 months will be completed in a subset of three hundred thirty (330) subjects enrolled in the study. Subjects will be randomly allocated to the angiographic subset at participating sites through the Interactive Voice Response System (IVRS). Eligible subjects will have annual follow-up until 5 years post-index procedure.

Official Title
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A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
* Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement


Participation Criteria
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Eligibility Criteria
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Clinical Inclusion Criteria: Subject is ≥ 18 years old Eligible for percutaneous coronary intervention (PCI) Documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia Acceptable candidate for coronary artery bypass grafting (CABG) Left ventricular ejection fraction (LVEF) is ≥ 30% Subject (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 Subject willing to comply with all specified follow-up evaluations Clinical Exclusion Criteria: Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine Known hypersensitivity to paclitaxel Known allergy to stainless steel Known allergy to platinum Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure Previous treatment with intravascular brachytherapy in the target vessel Planned PCI or CABG post-index procedure Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement Myocardial infarction (MI) within 72 hours prior to index procedure Cerebrovascular accident (CVA) within the past 6 months Cardiogenic shock Acute or chronic renal dysfunction Prior anaphylactic reaction to contrast agents Leukopenia Thrombocytopenia Thrombocytosis Active peptic ulcer or active gastrointestinal (GI) bleeding Current treatment, or past-treatment within 12-months of the index procedure, with paclitaxel or other chemotherapeutic agents Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure Known intention to procreate within 9 months after the index procedure Positive pregnancy test within 7 days before the index procedure, or lactating Life expectancy of less than 24 months due to other medical conditions Co-morbid condition(s) that could limit subject's ability to comply with study follow-up requirements or impact study scientific integrity Currently participating in another investigational drug or device study Angiographic Inclusion Criteria: Target Lesion Target lesion located in native coronary artery Target lesion must be de novo Target lesion diameter stenosis ≥ 50% Reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 4.0 mm Cumulative target lesion length ≤ 28 mm (area to be treated may be composed of multiple lesions but must be completely coverable by one study stent) Target lesion is successfully pre-dilated One non-target lesion may be treated in a non-target vessel as follows: Non-target lesion in non-target vessel must be treated with commercially available TAXUS stent if use of drug eluting stent required Treatment must be deemed a clinical angiographic success, without requiring use of unplanned additional stents(s) Treatment must be completed prior to treatment of target vessel Angiographic Exclusion Criteria Target lesion located in left main artery, whether protected or unprotected Target lesion is a chronic total occlusion (TIMI flow ≤ 1) Target lesion is restenotic Target lesion is located in a saphenous vein graft or mammary artery graft Target lesion is accessed via saphenous vein graft or mammary artery graft Target lesion is < 5 mm from bare metal stent (BMS) Target lesion < 5 mm from ostium Target lesion < 5 mm from side branch vessel ≥ 2.0 mm in diameter (Exceptions: subject may be enrolled if side branch is 100% occluded or if side branch is protected with a patent graft) Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in target vessel at a location with ≥ 2.0mm RVD Target lesion and/or target vessel proximal to target lesion moderately or severely calcified Target lesion and/or target vessel proximal to target lesion severely tortuous Target lesion located within or distal to a > 60° bend in target vessel Target vessel with angiographic presence of probable or definite thrombus Unprotected left main coronary artery disease Protected left main coronary artery disease with target lesion in Left Anterior Descending artery (LAD) or Left Circumflex artery (LCx). Subject may be enrolled if only lesion is target lesion in Right Coronary Artery (RCA)

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAXUS Element<br> | Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation<br>* TAXUS Element stent placement<br>|
| Active Comparator: TAXUS Express<br> | Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement<br>* TAXUS Express Stent Implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel. | The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure. | 12 months post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure | The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment (in-segment) is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent. | 9 months post-index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-eluting stent, paclitaxel-eluting stent, DES