First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease

Inclusion criteria

• ✓. Age ≥ 18 years and of age of legal consent.
• ✓. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) \<0.90/0.80.
• ✓. A single superficial femoral artery lesion with \>50% stenosis or total occlusion.
• ✓. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.
• ✓. Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment.
• ✓. Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
• ✓. Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot.
• ✓. The target lesion(s) can be successfully crossed with a guide wire and dilated.

Exclusion criteria