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

• MAE rate [ Time Frame: 30 days, 6 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]
• Assisted primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Stent integrity [ Time Frame: 6, 12, 24, 36 Months ] [ Designated as safety issue: Yes ]
• Acute success (device, lesion, procedure) [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
• Change in quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
• All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

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 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 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 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.