A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries. (VBXFLEX)

Inclusion Criteria:

1. Patient is at least 18 years old;
2. Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
3. Patient or legal representative is willing to give written informed consent;
4. Patient is capable of complying with protocol requirements, including all follow-up visits;
5. Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
6. Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
7. Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
8. Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
9. Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).
10. Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;
11. Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;
12. Patient has the device advanced across the target lesion(s) and positioned for deployment.

Exclusion Criteria:

1. Patient has a life expectancy of less than 1 year;
2. Patient has a known allergy to stent graft components, including stainless steel or heparin;
3. Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
4. Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
5. Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);
6. Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;
7. Patient has a known hypercoagulability that cannot be corrected;
8. Patient has evidence of a blood borne infection;
9. Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
10. 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;
11. Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
12. Patient is currently participating in this or another investigative clinical study.
13. Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
14. Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
15. Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
16. Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
17. 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.