The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study

This study is being conducted to collect 9 month safety and efficacy data on the Assurant
Cobalt Iliac Stent for all subjects enrolled into the study.

Inclusion Criteria:

- The lesion(s) is either de novo or restenotic in nature, located in the common iliac
artery and/or the external iliac artery;

- The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥
50% .

- The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate;

- The lesion length is < 100 mm (10 cm)

Exclusion Criteria:

- Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or
tortuousity,or heavily calcified.

- Tissue loss in the target extremities.

- The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft
anastomosis;

- The target lesion is in an aneurysm or associated with an aneurysm in the vessel
segment either proximal or distal to the target lesion.

- The lesion requires treatment other than percutaneous transluminal angioplasty (PTA)
prior to stent placement;

- Other lesions requiring treatment or surgery within 30 days of the procedure (pre or
post) with the exception of the non-target lesion(s).

- Inadequate distal run-off.

- History of bleeding diatheses or coagulopathy or will refuse blood transfusions;

- Creatinine > 2.5 mg/dl

- Platelet count <80,000 cells/mm3 or >700,000 cells/mm3, or a white blood cell (WBC)
of <3,000 cells/mm3

- Participation in another investigational device or drug study and has not completed
the primary endpoint(s) or that clinically interferes with the study endpoints;

- Previously enrolled in the Study.