A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

• Subjects age 18 and older.

• Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits. NOTE: For subjects less than 20 years of age enrolled at a Japanese center, the subject's legal representative, as well as the subject, must provide written informed consent.

• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.

• Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA:

• Degree of stenosis ≥ 70% by visual angiographic assessment

• Vessel diameter ≥ 4 and ≤ 6 mm

• Total lesion length (or series of lesions) ≥ 30 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or up to two Zilver PTX stents)

• Long Lesion Substudy: Total lesion length (or series of lesions) >140 mm and ≤ 190 mm (Note: Lesion segment(s) will require overlapping of two ELUVIA stents).

• For occlusive lesions requiring use of re-entry device, lesion length ≤ 120 mm

• Long Lesion Substudy: For occlusive lesions requiring use of re-entry device, lesion length > 120 mm and ≤ 170 mm

• Target lesion located at least three centimeters above the inferior edge of the femur

• Patent infrapopliteal 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 with no planned intervention.