LEVANT 2 Safety Registry

Clinical Inclusion Criteria:

1. Male or non-pregnant female ≥18 years of age;

2. Rutherford Clinical Category 2-4;

3. Patient is willing to provide informed consent, is geographically stable and comply
with the required follow up visits, testing schedule and medication regimen;

Angiographic Lesion Inclusion Criteria:

4. Length ≤15 cm;

5. Up to two focal lesions or segments within the designated 15 cm length of vessel may
be treated (e.g. two discrete segments, separated by several cm, but both falling
within a composite length of <15 cm);

6. ≥70% stenosis by visual estimate;

7. Lesion location starts ≥1 cm below the common femoral bifurcation and terminates
distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;

8. de novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty
procedure;

9. Lesion is located at least 3 cm from any stent, if target vessel was previously
stented;

10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available
device size matrix;

11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing
of lesion;

12. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by
angiography (treatment of target lesion acceptable after successful treatment of
inflow artery lesions); NOTE: Successful inflow artery treatment is defined as
attainment of residual diameter stenosis ≤30% without death or major vascular
complication.

13. At least one patent native outflow artery to the ankle, free from significant (≥50%)
stenosis as confirmed by angiography that has not previously been revascularized
(treatment of outflow disease is NOT permitted during the index procedure);

14. Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30
days after the protocol treatment in order to avoid confounding complications;

15. No other prior vascular interventions within 2 weeks before and/or planned 30 days
after the protocol treatment.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

1. Pregnant or planning on becoming pregnant or men intending to father children;

2. Life expectancy of <5 years;

3. Patient is currently participating in an investigational drug or other device study or
previously enrolled in this study; NOTE: Enrollment in another clinical trial during
the follow up period is not allowed.

4. History of hemorrhagic stroke within 3 months;

5. Previous or planned surgical or interventional procedure within 2 weeks before or
within 30 days after the index procedure;

6. History of MI, thrombolysis or angina within 2 weeks of enrollment;

7. Rutherford Class 0, 1, 5 or 6;

8. Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum
creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);

9. Prior vascular surgery of the index limb, with the exception of remote common femoral
patch angioplasty separated by at least 2 cm from the target lesion;

10. Inability to take required study medications or allergy to contrast that cannot be
adequately managed with pre- and post-procedure medication;

11. Anticipated use of IIb/IIIa inhibitor prior to randomization;

12. Ipsilateral retrograde access;

13. Composite lesion length is >15 cm or there is no normal proximal arterial segment in
which duplex flow velocity can be measured;

14. Significant inflow disease. Successful treatment of inflow disease allowed prior to
target lesion treatment;

15. Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three
tibial vessels), or planned future treatment of vascular disease distal to the target
lesion;

16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target
vessel;

17. Severe calcification that renders the lesion un-dilatable;

18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty,
scoring/cutting balloon, etc.).