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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease

Conditions
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Stenosis of Artery, Peripheral Arterial Disease, Iliac Artery Disease, Iliac Artery Occlusion

Intervention / Treatment
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* Device: Placement of WRAPSODY stent graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed informed consent Subject is ≥ 21 years of age Subject is able and willing to comply with study requirements Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4 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) Total lesion(s) length is ≤ 110mm Target lesion(s) is at least 3 cm from an existing stent or stent graft At least 1 stenosis in the target vessel has ≥ 50% stenosis Target vessel diameter is between 4.6 and 14.4mm at angiographic screening for device placement Adequate ipsilateral blood flow, including at least 1 patent (<50% stenotic) superficial femoral or profundal femoral artery 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: Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) <30 days from the date of the index study procedure Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure Previous or planned bypass surgery in the target limb(s) Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure Subject has had a stroke within 90 days prior to the index study procedure Subject has had a transient ischemic attack within 30 days prior to the index study procedure Uncorrectable coagulation disorder Subject cannot receive heparin, dual antiplatelet treatment, or anticoagulant(s) appropriate in the opinion of the investigator Condition unrelated to study anticipated to require indefinite anticoagulation Evidence of blood borne infection Hypersensitivity to nickel titanium alloy Allergy to radiographic contrast material which cannot be adequately premedicated Serum creatinine >2.5mg/dL The subject is enrolled in another investigational study Life expectancy is ≤ 12 months Active malignancy other than non-melanomatous skin cancer Stenosis/restenosis is located within a previously placed stent or stent graft Angiographic evidence of thrombus within or adjacent to the target lesion(s) Aneurysmal dilation proximal or distal to the target lesion(s) that could interfere with placement of the study device Abdominal aortic artery stent, if it could interfere with placement of the study device Target lesion(s) are located such that the stent graft would prevent blood flow to the internal iliac artery, if patent Lesions requiring atherectomy or ablation to facilitate stent graft delivery Any other condition deemed exclusionary in the opinion of the investigator for documented reasons relating to the health and/or welfare of the subject

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Approximately 30 subjects will be enrolled and treated with the study device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Treated with stent graft<br>This is a single arm study. All subjects will be treated with the WRAPSODY stent graft. | Device: Placement of WRAPSODY stent graft<br>* Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint of subjects free from specified adverse events | 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. | 4 weeks after placement of WRAPSODY stent graft | 
| Effectiveness endpoint of subjects with improvement of Rutherford Category | 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. | 4 weeks after placement of WRAPSODY stent graft | 
| Effectiveness endpoint of subjects with patency | 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. | 4 weeks after placement of WRAPSODY stent graft | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAOD, Peripheral Arterial Occlusive Disease, Iliac Artery Disease, Stent Graft