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 e…