A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

Inclusion Criteria: * Male or female ≥18 and \< 85 years of age; * Documented diagnosis of peripheral arterial disease (PAD) with Rutherford Classification stages 2-4; * Patient is willing to provide informed consent and comply with the required - follow up visits, testing schedule and medication regimen; Angiographic Criteria * Single lesion or up to two focal lesions (not separated by \>3 cm) (total vessel segment length ≤20 cm) in native superficial femoral and/or popliteal arteries; * ≥70% diameter stenosis by visual estimate; * Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk; * De novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure; * Lesion is located at least 3 cm from any stent, if target vessel was previously stented; * Target vessel diameter between ≥4 and ≤7 mm and able to be treated with available device size matrix; * Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion; * A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow iliac and/or common femoral artery lesions); * No vascular interventions, surgical or interventional procedures within 2 weeks before and/or planned 30 days after the protocol treatment. Exclusion Criteria Patients will be excluded if ANY of the following conditions apply: * Breastfeeding or pregnant or planning on becoming pregnant or men intending to father children; * Life expectancy of \< 2 year; * Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; * History of stroke within 3 months; * History of MI, thrombolysis or angina within 2 weeks of enrollment; * Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis); * Diagnosed active systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure * Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion; * Inability to take required study medications or allergy to paclitaxel or paclitaxel related compounds or contrast that cannot be adequately managed with pre- and post-procedure medication; * The lesion is a post-DCB restenosis, or within or adjacent to an aneurysm; Ipsilateral retrograde access; * There is no normal proximal arterial segment in which duplex flow velocity can be measured; * Known inadequate distal outflow (≥50% stenosis of distal popliteal and/or all three tibial vessels;), or planned future treatment of vascular disease distal to the target lesion; * Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel; * Severe calcification that renders the lesion un-dilatable or failed pre-dilatation, defined by a residual stenosis \>50% or major flow limiting dissection; * Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, embolic protection device, etc.).