A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions
Inclusion Criteria:
Clinical Inclusion Criteria
- Subject is ≥ 18 years old and ≤ 80 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 with documented ischemia
(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
Angiographic Inclusion Criteria (visual estimate)
- Target lesion located in native coronary artery
- Target lesion must be de novo
- Target lesion diameter stenosis > 50%
- Reference vessel diameter (RVD) > 2.75mm to < 4.0mm
- Cumulative target lesion length < 28 mm (area to be treated must be completely
coverable by one study stent)
- Target lesion is successfully pre-dilated. Subjects are enrolled after successful
balloon catheter pre-dilation of the target lesion and assignment to treatment arm by
IVRS.
- One non-target lesion may be treated in a non-target vessel
- Non-target lesion in non-target vessel must be treated with a 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 stent(s).
- Treatment must be completed prior to treatment of target lesion.
Exclusion Criteria:
Clinical Exclusion Criteria
- Contraindication to 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 the index procedure as defined
per protocol definition (see Appendix A)
- Cerebrovascular accident (CVA) within the past 6 months
- Cardiogenic shock characterized by systolic pressure < 80mm Hg and/or central filling
pressure > 20 mm Hg, or cardiac index < 1.8 liters/minute/m2 or intra-aortic balloon
pump or intravenous inotropes are needed to maintain a systolic pressure > 80 mm Hg
and a cardiac index > 1.8 liters/minute/m2
- Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or 177 μmol/l)
- Any prior true anaphylactic reaction to contrast agents; defined as known
anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that
cannot be adequately pre-medicated prior to the index procedure
- Leukopenia (leukocyte count < 3.5 x 109/liter)
- Thrombocytopenia (platelet count < 100,000/mm3)
- Thrombocytosis (> 750,000/mm3)
- 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 agent(s)
- 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 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 the subject's ability to comply with study
follow-up requirements or impact the scientific integrity of the study
- Currently participating in another investigational drug or device study
Angiographic Exclusion Criteria (visual estimate)
- Target lesion 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 < 5mm from bare metal stent (BMS)
- Target lesion is < 5mm from ostium
- Target lesion is < 5 mm from a side branch vessel ≥ 1.5 mm in diameter
- Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in
target vessel
- Target lesion and/or target vessel proximal to the target lesion is moderately or
severely calcified
- Target lesion and/or target vessel proximal to the target lesion is severely tortuous
- Target lesion is located within or distal to a > 60° bend in the vessel
- Target lesion with angiographic presence of probable or definite thrombus
- Unprotected left main coronary artery disease
- Protected left main coronary artery disease with target lesion in LAD or LCx(subject
may be enrolled if only lesion is target lesion in RCA)