Table 1 Overview of Inclusion and exclusion criteria

Inclusion criteria

 a. Age ≥ 18

 b. Subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aortic bifurcation

 c. Severely stenotic occlusion target vessel (stenosis ≥ 80%)

 d. Subject has been informed on the nature of the study and has provided informed consent

 e. Subject is capable of meeting study requirements including presences at follow-up visits

Exclusion criteria

 a. Vessels of the cardiopulmonary, coronary or cerebral circulations

 b. Undersized vessel diameters (< 3 mm)

 c. Perforation of the vessel distally or proximally to the occlusion segment prior atherectomy

 d. Subintimal position of the guiding catheter or the guidewire

 e. Use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft

 f. Target is at vessel segment which includes tortuous course with radius of curvature <  = 40 mm

 g. Access pathway includes tortuous course with radius of curvature <  = 25 mm, in specific extremely sharp aortic bifurcation

 h. In aneurysmatically altered iliac vessel segments

 i. If the introducer sheath, the guide catheter, the guidewire or the BYCROSS™ sustains any visible damage, especially kinking

 j. In the fracture areas of broken stents

 k. Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure

 l. Persistent vasospasm

 m. Patient is pregnant