Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

Inclusion Criteria: 1. Male or non-pregnant, non-breastfeeding female ≥18 years of age; 2. Rutherford Clinical Category 3-5; 3. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen; 4. Significant stenosis (≥70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment; 5. Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and 6. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (\<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed). NOTE: Outflow must be assessed AFTER pre-dilatation NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow. Exclusion Criteria: Patients will be excluded if ANY of the following conditions apply: 1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry); 2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or 3. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).