Nellix Registry Study: EVAS-Global

Study Overview
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Brief Summary
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Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)

Official Title
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Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 18 years old Subject has signed informed consent for data release Subjects with with AAA and eligible for endovascular repair Exclusion Criteria: Currently participating in another study where primary endpoint has not been reached yet Known allergy to any of the device components 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study. | Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)<br>* The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.<br>* Other names: Nellix EVAS FORWARD 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Immediate Procedural Technical Success | Technical success is defined as successful delivery and deployment of the Nellix System in the planned location. | 30 Days | 
| Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs) | Safety endpoint is measured with the number of subjects who are reported freedome of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss > 1000mL at 30 Days post index procedure. | 30 Days | 
| Number of subjects with Aneurysm rupture | The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5). | 5 years | 
| Number of subjects with Conversion to open surgical repair | The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5). | 5 years | 
| Number of subjects with Endoleak of any type | The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized. | 5 years | 
| Number of subjects with Clinically significant migration | The number of patients with clinically significant migration will be summarized descriptively. | 5 years | 
| Number of subjects with Aneurysm enlargement | The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement. | 5 years | 
| Number of incidence with Secondary endovascular procedures | The overall secondary procedure incidence and the individual component incidence will be provided. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAA, Aortoiliac Aneurysm