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

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.