a randomized, double-blind, controlled study of the safety and performance of the nirx™ paclitaxel-coated conformer coronary stent

Conditions: Coronary Artery Disease

Summary: the clinical investigation is an international, prospective, double-blind, randomized safety and efficacy study. the purpose of this study is to evaluate the safety and performance of the nirx(tm) paclitaxel-coated stent (1.0µg/mm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system)in patients who present for stenting of de novo lesions of a native coronary artery.

the primary objective of this study is to evaluate the safety and performance of coronary artery stenting with the nirx(tm) paclitaxel-coated stent (1.0µg/mm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system) for the treatment of de novo lesions in native vessels. patients in 2 sequential cohorts will be randomised to receive either the nirx(tm) paclitaxel-coated stent or the uncoated control stent. in cohort 1, the slow-release formulation nirx(tm) paclitaxel-coated stent will be studied. if the safety profile is acceptable, the moderate-release formulation nirx(tm) paclitaxel-coated stent will be studied in cohort 2. in each f the 2 cohorts, 133 patients will be treated with the nirx(tm) paclitaxel-coated stent and 133 with the uncoated control stent (1.1 ratio), for a total of 532 patients in study.

Eligibility criteria:
general inclusion criteria: * patient \>= 18 years old. * eligible for percutaneous transluminal coronary angioplasty (ptca). * patient (or legal guardian) understands the study requirements and the stent treatment procedure and provides written informed consent before any study-specific tests or procedures are performed. * willing to comply with all specified follow-up evaluations. * documented stable angina pectoris (canadian cardiovascular society classification \[ccs\] 1, 2, 3, or 4), unstable angina pectoris with documented ischemia (braunwald class ib - c, iib - c, or iiib - c), or documented silent ischemia. * acceptable candidate for cabg. angiographic inclusion criteria: * target lesion is located within a native coronary vessel. * target lesion is de novo (i.e., a coronary lesion not previously treated). * target lesion diameter stenosis \>= 50% and \<= 99% (visual estimate or on-line qca). * target lesion \<= 12 mm in length (visual estimate or on-line qca). * target vessel \>= 3.0 mm and \<= 3.5 mm in diameter (visual estimate or on-line qca). general exclusion criteria: * known sensitivity to paclitaxel. * patient has received paclitaxel or other anti-mitogenic agent within 12 months prior to planned enrollment in the study. * patient has previous stent procedure with any drug-coated or drug-eluting stent device. * patient has undergone any coronary intervention within 30 days prior to stent placement associated with this protocol. * patient anticipates planned additional intervention (staged procedure) to any non-target coronary vessel within 45 days after the stent placement associated with this protocol. * mi within 72 hours of planned stent placement. * left ventricular ejection fraction (lvef) of \< 30%. * stroke within the past 6 months. * acute or chronic renal dysfunction (creatinine \>1.7 mg/ml or \>150 µmol/l). * acetylsalicylic acid and/or clopidogrel and/or ticlopidine are contraindicated. * leukopenia (leukocytes \<3.5 x 109/liter). * thrombocytopenia (platelets \<100,000/mm3). * active peptic ulcer or active gastrointestinal (gi) bleeding. * known allergy to stainless steel. * previously enrolled in the nirx(tm) coronary stent clinical safety and performance study. * currently enrolled in another investigational device or drug study and has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days prior to enrollment in this study. * patient is lactating, has a positive pregnancy test within 7 days of planned stent placement, or intends to become pregnant during the study (only applies to female patients of child-bearing potential). * life expectancy of less than 24 months because of other medical conditions. * co-morbid condition(s) that could limit the patient's ability to participate in the study or comply with follow-up requirements or co-morbid condition(s) that could impact the scientific integrity of the study. angiographic exclusion criteria: * unprotected left main coronary artery disease (or obstruction greater than 50% in the left main coronary artery that is not protected by at least 1 non-obstructed bypass graft to the left anterior descending \[lad\] or circumflex artery or a branch thereof). * target lesion is in a previously stented segment. * target vessel was treated with directional coronary atherectomy, laser, or transluminal extraction catheter prior to stent placement. * target lesion is ostial in location (within 3 mm of vessel origin). * target site of stent placement has side branches \>2.0 mm in diameter. * target lesion is severely calcified (by visual estimate) * target vessel has closed abruptly or is threatening closure. * target lesion is located within or immediately distal to a \>60° bend in the vessel. * target vessel has diffuse disease requiring more than one 15 mm stent for full lesion coverage. * target lesion involves a bifurcation where a branch vessel greater than 2.0 mm in diameter originates (either stenosis of both main vessel and major branch or stenosis of just major branch). * target lesion has excessive tortuosity unsuitable for stent delivery and deployment. * target lesion is located within a saphenous vein bypass graft. * target lesion is located in a vessel section supplied by distal graft.

Keywords: coronary artery disease percutaneous coronary intervention stent implant drug-coated stent