The COPPER-B Trial

General Inclusion Criteria: * Willing and able to provide informed consent and comply with all study requirements; * Candidate for an infrapopliteal percutaneous intervention; * Must be ≥ 18 years of age; * Rutherford category 3-6; * Willing and able to tolerate dual anti-platelet therapy (DAPT) for a minimum of one (1) month; * Labwork within acceptable limits according to standard of care; * INR \< 2.0 if on warfarin or not on warfarin; * Sheath size used for the interventional procedure 6F, 7F, or 8F. General Exclusion Criteria: * Life expectancy \< one (1) year; * Planned amputation prior to procedure; * Pregnancy or nursing (a pregnancy test is required for all women of childbearing capabilities ≤ 7 days prior to the index procedure); * Previous intervention of the target vessel with a drug eluting balloon, or drug delivery catheter; * Acute limb ischemia; * Known allergy to paclitaxel; * Known hypersensitivity to other drugs manufactured in Cremophor® EL (polyoxyethylated castor oil; e.g. Drugs containing polyoxyethylated castor oil are drugs such as miconazole, cyclosporine injection, nelfinavir mesylate, saperconazole, tacrolimus, and xenaderm ointment); * Known allergy to anticoagulants; * Known TRUE acetylsalicylic acid (ASA) allergy; * Use of glycoprotein (GP) IIb/IIIa inhibitors during the procedure visit within 30 days prior to the index procedure; * Target lesion treated with a cryoplasty balloon at the time of the index procedure; * Current enrollment in another investigational device or drug study; * After obtaining informed consent, at any point up to introduction of the OPC, the investigator determines the study subject is not appropriate for the study; * Hemorrhagic stroke within three (3) months; * Renal failure or chronic kidney disease with GFR ≤30 ml/min or MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or patient is on dialysis); * Prior vascular surgery of the index limb. Angiographic Inclusion Criteria * Reference vessel diameter (RVD) ≥ 2mm and ≤ 4mm; * Single or multiple lesions in the infrapopliteal arteries (AT, PT, peroneal); * If single lesion treatment, the minimum lesion length required is 2cm; * Lesion location must in the area from the origin of the trifurcation vessel to the ankle (top of the talus bone); * Minimum of one vessel run-off; * Pre-intervention percent DS ≥ 70%; * Target vessel reconstitutes at/above the ankle; * Infrapopliteal treatment prior to infrapopliteal OPC treatment resulting in ≤ 30% residual stenosis; * Infrapopliteal interventional treatment length is within the area of 1cm below the level of the knee joint to the malleolus, except in the case where an anomalous take-off of an infrapopliteal artery comes of at mid-knee joint. Angiographic Exclusion Criteria * Flow limiting dissection requiring stent placement; * Post PTA residual stenosis \> 30% as visualized by treating physician; * Perforation requiring a covered stent; * Lesion is above the trifurcation; * In-stent restenosis in target vessel; * Significant (≥ 50% DS) inflow lesion or occlusion left untreated in the ipsilateral Iliac, SFA, or popliteal artery proximal to the target lesion; * Lesions in the target vessel not treated with the OPC; * Visible thrombus in the target artery or proximal to the target artery.