Eine klinische Studie um die Ergebnisse bei Behandlung von Verschlüssen der Blutgefäße im Oberschenkel durch den ELUVIA™-Stent (ein Stent der ein Medikament freisetzt) zu den Ergebnissen durch Stents ohne Medikamentenfreisetzung zu vergleichen.

Device: Peripheral stenting

Inclusion Criteria:

1. Subjects age 18 and older

2. Subject 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

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

4. Stenotic, restenotic or occlusive lesion(s) located in the native Superficial Femoral
Artery (SFA) and/or Proximal Popliteal Artery (PPA):

1. Degree of stenosis = 70 % by visual angiographic assessment

2. Vessel diameter = 4 and = 6 mm

3. Total lesion length (or series of lesions) = 30 mm and =210 mm (Note: Lesion
segment(s) must be fully covered with one or two overlapping ELUVIA stent(s) or
Self Expanding Bare Nitinol stent(s))

4. For occluded lesions (chronic occlusions) requiring use of re-entry device,
lesion length = 180 mm

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

5. 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

Exclusion Criteria:

1. Previously stented target lesion/vessel

2. Target lesion/vessel previously treated with drug-coated balloon within 12 months
prior to randomization/enrollment

3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat
atherosclerotic disease

4. Use of atherectomy, laser or other debulking devices such as Rotarex in the target
limb SFA/PPA during the index procedure

5. History of major amputation in the target limb

6. Documented life expectancy less than 24 months due to other medical co-morbid
condition(s) that could limit the subject's ability to participate in the clinical
study, limit the subject's compliance with the follow-up requirements, or impact the
scientific integrity of the clinical study

7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the
investigator, cannot be adequately pre-medicated

8. Known hypersensitivity/allergy to the stent system or protocol related therapies
(e.g., nitinol, paclitaxel, or structurally related compounds, polymer or individual
components, and antiplatelet, anticoagulant, thrombolytic medications)

9. Platelet count less than 80000 mm3 or more than 600000 mm3 or history of bleeding
diathesis

10. Concomitant renal failure with a serum creatinine higher than 2.0 mg/dL

11. Receiving dialysis or immunosuppressant therapy

12. History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within
6 months prior to randomization/enrollment

13. Unstable angina pectoris at the time of randomization/enrollment

14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years

15. Current participation in an investigational drug or device clinical study that has not
completed the primary endpoint at the time of randomization/ enrollment or that
clinically interferes with the current study endpoints (Note: studies requiring
extended follow-up for products that were investigational, but have become
commercially available since then are not considered investigational studies)

16. Septicemia at the time of randomization/enrollment

17. Presence of other hemodynamically significant outflow lesions in the target limb
requiring intervention at the time of the index procedure

18. Presence of aneurysm in the target vessel

19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to
randomization/enrollment

20. Perforated vessel as evidenced by extravasation of contrast media prior to
randomization/enrollment

21. Heavily calcified lesions

22. As applicable by French law, subject who is a protected individual such as an
incompetent adult or incarcerated person