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