PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis

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; * Previous history of native coronary bare metal stenting ≥60 days; * LVEF ≥25%; * Patient is an acceptable candidate for PTCA, stenting, and emergent CABG; * Patient is willing to provide informed consent and comply with follow-up visits and testing schedule; * Target lesion is in a native coronary with previous single bare metal stent; Stenosis is ≥50% and \<100% by visual estimate or QCA prior to defined pre-dilatation; * Reference Vessel Diameter (RVD) is ≥2.5 and ≤3.25; * Target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous Lutonix Catheters; * Guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment; * Enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. Successful treatment is defined as ≤30% residual stenosis with TIMI III flow and no evidence of dissection. Exclusion Criteria: * History of Stroke within past 6 months; * History of MI or thrombolysis within 72 hours of randomization; * History of previous target vessel perforation; * Prior vascular brachytherapy; * 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 in the Left Main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm; * Target lesion is planned to be treated with something other than PTCA (i.e. stent, cutting balloon, atherectomy, VBT, etc.); * Uncontrollable allergies to procedure medications, materials, or contrast; * Patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel; * Known sensitivity to paclitaxel or other antimitogenic agent; * Patient has a stent sandwich (a stench previously deployed within another stent; * Pre-procedure CKMB \>2x 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 anti-platelet therapy or it will need to be withdrawn for a planned procedure; * The patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study;