Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)

Inclusion Criteria

• Patient is at least 18 years old;
• Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
• Patient or legal representative is willing to give written informed consent;
• Patient is capable of complying with protocol requirements, including all follow-up visits;
• Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
• Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery

Exclusion Criteria

• Patient has a life expectancy of less than 1 year;
• Patient has a known allergy to stent graft components, including stainless steel or heparin;
• Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
• Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
• Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment;
• Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure;
• Patient is currently participating in this or another investigative clinical study.
• Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
• Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
• Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
• Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent