The overall goal of the study is to evaluate the safety and efficacy of the IDEV SUPERA® Nitinol Stent System in treating patients with obstructive superficial femoral artery disease – commonly known as superficial femoral artery (SFA). The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of PTA alone.
Principal Investigators: Adam Brodsky, MD
Enrollment Status: Open