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 Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter.
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 peak systolic velocity ratio \<=2.4 at 12 month follow-up visit with no target lesion revascularization or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States
Edward Hospital
Naperville, Illinois, United States
Primary Patency (Peak Systolic Velocity Ratio<=2.4)
Peak systolic velocity ratio \<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass
Time frame: 12 months
Target Lesion Revascularization Rate
To examine, describe and compare/contrast within and between Drug Coated Balloon groups. 1. Target lesion revascularization rate 2. Safety event rate 3. Healthcare utilization costs
Time frame: 12 months
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Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Prairie Education and Research Collaborative
Springfield, Illinois, United States