The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut
from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each
connected to the next in a unique pattern to allow for flexibility and vessel
conformability. Each segment consists of two struts and a crown (Figure 1). It is designed
to produce optimal luminal diameter and increased scaffolding, and to maintain luminal
patency.

Inclusion Criteria:

1. Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50%
and ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.

2. Target lesion located at least 1 cm distal to the take-off of the profunda femoris
artery and at least 3 cm proximal to the highest point of the cortical margin of the
femur;

3. Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);

4. Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);

5. Adequate distal run-off to the ankle in the target limb (defined as having at least
one patent calf vessel <50% stenosed;

6. Life expectancy >12 months.

Exclusion Criteria:

7. Women who do not have a negative serum or urine pregnancy test documented within 7
days prior to enrollment;

8. Any condition that precludes safe access with percutaneous transluminal angioplasty
(PTA) devices, such as: excessive peripheral artery disease, unresolved fresh
thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively
tortuous or calcified;

9. Lesions in contralateral SFA/PPA that require intervention during the index
procedure, or within 30 days before or after the index procedure;

10. Previous treatment to the target lesion within the 3 months prior to enrollment;
previous femoropopliteal bypass in target vessel; previous stenting of the target
lesion;

11. Target lesion located within an aneurysm or associated with an aneurysm in the vessel
segment either proximal or distal to the target lesion;

12. Target lesion requires treatment other than standard PTA prior to stent placement
(i.e., no other devices or procedures such as cutting balloons and laser atherectomy
are permitted to be used during the index procedure);

13. History of bleeding diatheses or coagulopathy or will refuse blood transfusions;

14. Known impaired renal function, defined as creatinine >2.5 mg/dl;

15. Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;

16. Known white blood cell (WBC) of <3,000 cells/mm3;

17. Participation in another investigational device or drug study and has not completed
the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study
endpoints, or previously enrolled in the Complete SE SFA Study.