Iliac Artery Disease, Iliac Artery Occlusion, Peripheral Arterial Disease, Stenosis of Artery
Conditions
Keywords
PAOD, Peripheral Arterial Occlusive Disease, Iliac Artery Disease, Stent Graft
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPlacement of WRAPSODY stent graft
Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.
Sponsors
Merit Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Approximately 30 subjects will be enrolled and treated with the study device
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint of subjects free from specified adverse events | 4 weeks after placement of WRAPSODY stent graft | 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. |
| Effectiveness endpoint of subjects with improvement of Rutherford Category | 4 weeks after placement of WRAPSODY stent graft | The primary clinical effectiveness endpoint is the proportion of subjects with improvement of at least 1 Rutherford category within 4 weeks of the index procedure. Composite with Outcome 3. |
| Effectiveness endpoint of subjects with patency | 4 weeks after placement of WRAPSODY stent graft | The primary clinical effectiveness endpoint is the proportion of subjects with patency as evaluated by duplex ultrasound at 4 weeks after index procedure. Composite with Outcome 2. |
Outcome results
None listed