De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions

Inclusion Criteria:

• Male or non-pregnant/non-breast feeding Female ≥ 18 years of age. Women of childbearing potential must have a negative pregnancy test (within 7 days of the procedure);
• Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia;
• Left ventricular ejection fraction (LVEF) ≥ 25%;
• Patient is an acceptable candidate for PTCA, stenting, and emergent coronary artery bypass grafting (CABG);
• Patient is willing to provide informed consent and comply with follow-up visits and testing schedule;
• Target lesion is a de novo lesion in a native coronary artery vessel;
• Initial stenosis is ≥ 50% and < 100% by visual estimate or quantitative coronary angiography (QCA);
• Reference Vessel Diameter (RVD) is ≥ 2.5 and ≤ 3.25 prior to predilation;
• Target lesion is ≤18mm in length and can be treated in its entirety by no more than 1 single Lutonix Catheter balloon and 1 single BMS;
• Guidewire is able to cross lesion and be placed in distal vessel prior to enrollment;
• Enrollment permitted after successful treatment of 1 non-study lesion in a single other non-study vessel (not in the same vascular territory as the study lesion). Successful treatment is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of dissection.

Exclusion Criteria:

• History of stroke within past 6 months;
• History of myocardial infarction (MI) or thrombolysis within 72 hours of randomization;
• Prior vascular brachytherapy;
• Uncontrollable allergies to procedure medications, materials or contrast;
• Angiographic evidence of thrombus or dissection within the target vessel;
• Intervention of another coronary lesion ≤ 60 days before index procedure day or planned following index procedure;
• Target lesion is planned to be treated with something other than PTCA and stent (i.e., cutting-balloon, atherectomy, vascular brachytherapy (VBT), etc.);
• Target lesion is in the Left Main and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥ 2.5mm;
• Known sensitivity or has received paclitaxel or other antimitogenic agent within 12 months prior to target vessel treatment;
• Patient has any previous intervention (PTCA, stent, etc.) of the target coronary vessel;
• Any medical condition, in the investigators opinion, that should preclude the patient from the study or patient has a life expectancy less than 24 months;
• Known creatine kinase-MB (CKMB) > 2x upper limit of normal (ULN) or positive Troponin;
• Creatinine > 2.0 mg/dl;
• Leukocyte < 3500/mL;
• Platelet < 100,000 mL or > 750,000 mL;
• Currently taking or must resume warfarin;
• Patient is contraindicated for antiplatelet therapy or it will need to be withdrawn for a planned procedure;
• The subject is currently participating in another investigational drug or device study.