The Complete® Self-Expanding Stent and Stent Delivery System Registry

Exclusion Criteria

• •Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity or a target lesion/vessel that is heavily calcified ;
• •Tissue loss in the extremity: category 5 or 6 on the Rutherford scale;
• •Target lesion has a previous stent, or is within a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
• •Target lesion is within an aneurysm or associated with an aneurysm in the vessel segment proximal or distal to the target lesion;
• •Lesion requires treatment with a non-standard device associated with Percutaneous Transluminal Angioplasty (PTA) prior to stent placement;
• •Inadequate distal run-off;
• •Planned interventional procedure or vascular surgery to target vessel within 30 days pre- or post-index iliac procedure;
• •History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
• •Platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or White Blood Count (WBC) \<3,000 cells/mm3;
• •Creatinine \>2.0 mg/dl;
• •Participation in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial or the subject has previously been enrolled in this Registry;