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

The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System

The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).

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.