Peripheral Artery Disease Clinical Trial
Official title:
A Prospective, Multicenter, Single Arm, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Femoropopliteal Arteries
The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.
The registry will enroll patients with claudication or critical limb ischemia due to stenotic
lesions in femoropopliteal arteries. All subjects meeting protocol criteria will be treated
with the LUTONIX Drug Coated Balloon Catheter for approved indications according to the
current Instructions for Use (IFU) and followed clinically for 2 years.
Total enrollment will be approximately 250 subjects at up to 18 sites. Subject follow-up will
occur at 1, 6, 12 and 24 months. The primary efficacy endpoint is freedom from target lesion
revascularization at 12 months.
The primary safety endpoint is freedom at 30 days from the composite endpoint of target
vessel revascularization and target lesion revascularization, major amputation and major
reintervention of index limb, and device- and procedure-related death.
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