The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.

Detailed Description
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This is a multicenter, multi-country prospective, single-arm, non-randomized clinical trial. The comparative control arm is a combination of patient data drawn from the abdominal aortic aneurysms (AAA) open surgical control arms of four commercially approved AAA devices as part of the Society of Vascular Surgeons. Patients enrolled in this study will be pre-screened and have a diagnosis of an infrarenal AAA with or without the need for treatment of iliac artery aneurysm, are candidates for endovascular repair, and meet the eligibility criteria. Patients enrolled in the study will participate in follow-up visits 31 days, 6 months and at 1 year following the index procedure. At the follow-up visits there will be a clinical assessment, blood collection, and abdominal CT imaging of the patient.

Official Title
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The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Device: The Nellix® EndoVascular Aneurysm Sealing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Informed consent form understood and signed and patient agrees to all follow-up visits Is able and willing to comply with clinical follow-up requirements for one year Is able and willing to undergo Contrast-Enhanced Spiral CT scans Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following; aneurysm ≥ 4.5 cm in diameter, or aneurysm is twice the diameter of the normal infrarenal aorta, or aneurysm is growing at a rate of ≥ 10 % per year Non-aneurysmal aortic neck length ≥ 5mm below the most inferior renal artery Proximal aortic neck diameter between 16 and 36mm Aortic neck angulation to the sac ≤ 60 Common iliac artery diameter 8 to 35mm bilaterally Aneurysm blood lumen diameter ≤ 60mm Iliac and femoral arteries suitable for endovascular access with the Nellix System Exclusion Criteria: Life expectancy ≤ 1 year Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative Aneurysm is thoraco-abdominal, suprarenal and/or mycotic Thoracic aneurysm ≥ 4.5cm in diameter AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries Presence of mural thrombus > 50% circumferentially in aortic neck Iliac aneurysm blood lumen diameter > 35mm Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure History of prior treatment of abdominal aortic or iliac artery aneurysm disease Femoral or iliac artery occlusive disease such that device delivery is not possible Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft Receiving dialysis History of hypercoagulability Allergy to IV contrast Serum creatinine level >2.0 mg/dL (or equivalent) Patient is pregnant or nursing Patient is currently enrolled in an investigational drug or device trial

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 Aneurysm Sealing<br>The Nellix® EndoVascular Aneurysm Sealing System | Device: The Nellix® EndoVascular Aneurysm Sealing System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety- Number of Major Adverse Events | The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure. | 30 day | 
| Device Performance | The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality | Any death occurring during the study period, regardless of cause | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Aneurysm, Abdominal, Endovascular Procedures