PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study

Study Overview
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Brief Summary
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The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.

Official Title
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Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation

Conditions
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Aortoiliac Aneurysms, Iliac Aneurysms

Intervention / Treatment
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* Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,
* Device: Atrium iCAST™
* Device: Zenith® Flex AAA Endovascular Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An aortioiliac or iliac aneurysm An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study Unwilling or unable to comply with the follow-up schedule Simultaneously participating in another investigative device or drug study

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zenith® Branch Endovascular Graft-Iliac Bifurcation<br>Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft | Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,<br>* Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.<br>* Other names: Branch Graft;Device: Atrium iCAST™<br>* Implantation of Atrium iCAST<br>Device: Zenith® Flex AAA Endovascular Graft<br>* Implantation of the Zenith Flex Endovascular Graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from morbidity (i.e., morbidity index) | Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases