Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in the 12 month patency (defined as PSVR <=2.4 at 12month follow-up visit with no TLR or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter.