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

An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction With Bare Metal Stenting in Patients With De Novo Coronary Lesions.

The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stenting (BMS). The purpose is to assess the feasibility, safety and efficacy of the Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct treatment strategies.

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.