ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

Atherosclerosis is a systemic disease that has become increasingly recognized in the
expanding elderly population as a significant cause of morbidity and mortality.
Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms
ranging from intermittent claudication to ischemic rest pain and critical ischemia with major
tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat
with endovascular therapy because the disease is often diffuse and located in an area of the
body subject to significant mobility stresses such as extension, contraction, compression,
elongation, flexion and torsion.

The IMPERIAL trial is a global, prospective, multi-center trial. Approximately 525-535
subjects will be enrolled at up to 75 study centers worldwide. Regions participating include
the United States, Canada, European Union, Japan and New Zealand.

The trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX),
controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded,
non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded,
non-randomized, Long Lesion substudy.

Inclusion Criteria:

1. Subjects age 18 and older.

2. 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.

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 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

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 <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 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
trial, limit the subject's compliance with the follow-up requirements, or impact the
scientific integrity of the clinical trial.

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 investigational 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 <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.

10. Concomitant renal failure with a serum creatinine >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 another 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 within 30 days of randomization/enrollment.

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.