Advance® 18PTX® Balloon Catheter Study

Key Inclusion Criteria: * Age \>18 years. * Able to provide informed consent. * Has at least one de novo or restenotic lesion(s) with \> 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion. Key Exclusion Criteria: * Has significant stenosis (\> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure. * Lack of at least one patent runoff vessel with \< 50% stenosis throughout its course. * Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.