This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg. The device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a "CE mark," which means it meets the European Union's safety, health and performance standards. This trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.
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Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure.
Timeframe: 12-months post-index procedure
Freedom from Major Adverse Events (MAE) through 12 months
Timeframe: Through 12 months post-index procedure