The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to
 evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of
 peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic
 lesions in the common iliac artery (CIA) and/or external iliac artery (EIA), including
 lesions at the aortic bifurcation.
Approximately 30 subjects will be enrolled. Post study procedure subjects will have planned
 follow-up visits at 4 weeks, 24, 36 and 52 weeks, and unscheduled visits as medically
 necessary,

 The primary study safety endpoint is the proportion of subjects free from a composite of
 device- or procedure-related death, myocardial infarction, or amputation above the
 metatarsals in the treated leg resulting from a vascular event, or device- or
 procedure-related serious adverse events within 4 weeks of the index procedure. The primary
 clinical effectiveness endpoint is the proportion of subjects with a composite improvement of
 at least 1 Rutherford category and patency as evaluated by duplex ultrasound at 4 weeks after
 index procedure.
Inclusion Criteria:

 1. Subject has signed informed consent

 2. Subject is ≥ 21 years of age

 3. Subject is able and willing to comply with study requirements

 4. Male, infertile female, or female practicing contraception and a negative pregnancy
 test within 7 days prior to the study procedure

 5. Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4

 6. Angiographic evidence of de novo or restenotic target lesion(s) in native vessels in
 the common and/or external iliac artery(ies) (multiple stenoses may exist within the
 target lesion)

 7. Total lesion(s) length is ≤ 110mm

 8. Target lesion(s) is at least 3 cm from an existing stent or stent graft

 9. At least 1 stenosis in the target vessel has ≥ 50% stenosis

 10. Target vessel diameter is between 4.6 and 14.4mm at angiographic screening for device
 placement

 11. Adequate ipsilateral blood flow, including at least 1 patent (<50% stenotic)
 superficial femoral or profundal femoral artery

 12. Full expansion of an appropriately sized (in the investigator's opinion) standard
 angioplasty balloon has been achieved during primary angioplasty at the target lesion
 prior to enrollment

 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