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.