EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

Study Overview
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Brief Summary
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Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

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 safety and effectiveness outcomes. 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 Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)

Conditions
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Abdominal Aortic Aneurysm Without Rupture

Intervention / Treatment
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* Device: Nellix® System


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA A patient who meets all of the following criteria potentially may be included in the study: Male or female at least 18 years old; Informed consent form understood and signed Patient agrees to all follow-up visits; Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included. Anatomically eligible for the Nellix System (per Instructions For Use): Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm); Aneurysm blood lumen diameter ≤60mm; Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac; Most caudal renal artery to each hypogastric artery length ≥100mm; Common iliac artery lumen diameter between 9 and 35mm; Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm; Ability to preserve at least one hypogastric artery. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40 EXCLUSION CRITERIA A patient who meets none of the following criteria potentially may be included in the study: Life expectancy <2 years as judged by the Investigator; Psychiatric or other condition that may interfere with the study; Participating in another clinical study; Known allergy or contraindication to any device material; Coagulopathy or uncontrolled bleeding disorder; Ruptured, leaking or mycotic aneurysm; Serum creatinine (S-Cr) level >2.0 mg/dL; CVA or MI within three months of enrollment/treatment; Aneurysmal disease of the descending thoracic aorta; Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference); Connective tissue diseases (e.g., Marfan Syndrome); Unsuitable vascular anatomy that may interfere with device introduction or deployment; Pregnant (female 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
Interventional Model Description: Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System | Device: Nellix® System<br>* Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Adverse Events (MAE) | All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc | 30 days | 
| Rate of 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 |