The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease

Exclusion Criteria

• •1. Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) \<30 days from the date of the index study procedure
• •2. Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure
• •3. Previous or planned bypass surgery in the target limb(s)
• •4. Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure
• •5. Subject has had a stroke within 90 days prior to the index study procedure
• •6. Subject has had a transient ischemic attack within 30 days prior to the index study procedure
• •7. Uncorrectable coagulation disorder
• •8. Subject cannot receive heparin, dual antiplatelet treatment, or anticoagulant(s) appropriate in the opinion of the investigator
• •9. Condition unrelated to study anticipated to require indefinite anticoagulation
• •10. Evidence of blood borne infection
• •11. Hypersensitivity to nickel titanium alloy
• •12. Allergy to radiographic contrast material which cannot be adequately premedicated
• •13. Serum creatinine \>2.5mg/dL
• •14. The subject is enrolled in another investigational study
• •15. Life expectancy is ≤ 12 months
• •16. Active malignancy other than non-melanomatous skin cancer
• •17. Stenosis/restenosis is located within a previously placed stent or stent graft
• •18. Angiographic evidence of thrombus within or adjacent to the target lesion(s)
• •19. Aneurysmal dilation proximal or distal to the target lesion(s) that could interfere with placement of the study device
• •20. Abdominal aortic artery stent, if it could interfere with placement of the study device
• •21. Target lesion(s) are located such that the stent graft would prevent blood flow to the internal iliac artery, if patent
• •22. Lesions requiring atherectomy or ablation to facilitate stent graft delivery
• •23. Any other condition deemed exclusionary in the opinion of the investigator for documented reasons relating to the health and/or welfare of the subject