Table 1 Eligibility criteria for enrollment

Inclusion criteria

Age ≥ 18

Subject with documented symptomatic PAD (Rutherford 2–6) with de novo lesion eligible for percutaneous intervention

Target lesion is at least 10 mm distal to the SFA origin and at least 10 mm proximal to the distal end of the TPT

Degree of stenosis ≥ 80% based on CTA, MRA or angiography

Vessel lumen diameter ≥ 3.0 mm

Lesion length ≥ 3.0 cm

Subject has been informed on the nature of the study and is willing and able to provide informed consent

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

Exclusion criteria

Subject is unable to take antiplatelet drugs or anticoagulation

Vessel of the cardiopulmonary, coronary or cerebral circulation

Subject has anticipated life expectance < 12 month

Subject is diagnosed with impaired renal function (creatinine > 2.5 mg/dL)

Subject has undergone or planned surgical or endovascular procedure 15 days before or after the study procedure

Vessel lumen < 3.0 mm

Stent at access and target vessel or In-stent restenosis at target lesion

Target and/or access vessel includes by-pass graft

Target vessel is dissected

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

Access pathway includes tortuous course with radius of curvature <  = 25 mm

Target and/or access vessel includes aneurysmatically altered segments

Persistent vasospasm

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

Subject is pregnant or planning to become pregnant within the study period, or lactating mothers

Subject is enrolled to another clinical investigation that might interfere with this study