Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Detailed Description
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This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Official Title
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Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study

Conditions
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Abdominal Aortic Aneurysm (AAA)

Intervention / Treatment
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* Device: Nellix System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 18 years old; Informed consent understood and signed; Patient agrees to all follow-up visits; Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year. Anatomic eligibility for the Nellix System per the instructions for use: Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm); Aneurysm blood lumen diameter ≤60mm; Most caudal renal artery to aortoiliac bifurcation length ≥100mm; Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac; Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm; Ability to preserve at least one hypogastric artery. Exclusion Criteria: Life expectancy <2 years; Psychiatric or other condition that may interfere with the study; Participating in enrollment of another clinical study Known allergy to device any device component; Coagulopathy or uncontrolled bleeding disorder; Ruptured, leaking or mycotic aneurysm; Serum creatinine level >2.0mg/dL; CVA or MI within three months of enrollment/treatment; Aneurysmal disease of the descending thoracic aorta; Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference); Connective tissue diseases (e.g., Marfan Syndrome) Unsuitable vascular anatomy; Pregnant (females of childbearing potential only).

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: Nellix System<br>Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study. | Device: Nellix System<br>* Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events at 30 Days | Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc | 30 days | 
| Treatment Success at 1 Year | Treatment Success = procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events From 30 days to 5 years | Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc | >30 days to 5 years | 
| Clinical Utility Outcomes | anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time | At the time of procedure | 
| Time in ICU | Number of hours spent in the intensive care unit (ICU) | Up to 7 days | 
| Adverse Events | All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years | > 30 days to 5 years | 
| Aneurysm Rupture |  | > 30 days to 5 years | 
| Conversion to Open-Surgical Repair |  | >30 days to 5 years | 
| Device Performance | aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak | > 30 days to 5 years | 
| Mortality |  | > 30 days to 5 years | 
| Renal Dysfunction | assessment of estimated glomerular filtration rate (eGFR) | Post-procedure to 5 years | 
| Secondary Surgical Intervention | The number of additional surgical procedures to repair resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defects will be collected. | Post-procedure to 5 years | 
| Time to Hospital Discharge | Number of days spent in hospital | Up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EndoVascular, Infrarenal, Abdominal, Aortic, Aneurysm, AAA, Endologix, EVAS, Sealing, System