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

• Exclusion Criteria:
• Excessive 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 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 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.