The COPPER-B Trial (COPPER-B)

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.