TAXUS PERSEUS Small Vessel
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
Intervention description: TAXUS Element stent implantation
Intervention MeSH terms: Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: paclitaxel-eluting stent; PES

Summary:

      The purpose of the TAXUS PERSEUS Small Vessel 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 20 mm in length in
      native coronary arteries of ≥ 2.25 mm to < 2.75 mm diameter.
    

Eligibility criteria:

        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) ≥ 2.25 mm to < 2.75 mm

               -  Cumulative target lesion length ≤ 20 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 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)