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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• Main ID: NCT02048514
• Date of registration: 27/01/2014
• Prospective Registration: No
• Primary sponsor: Endologix
• Public title: The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
• Scientific title: The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
• Date of first enrolment: December 2008
• Target sample size: 69
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02048514
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Colombia, Latvia, New Zealand, Venezuela

Key inclusion & exclusion criteria

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;

1. aneurysm = 4.5 cm in diameter, or

2. aneurysm is twice the diameter of the normal infrarenal aorta, or

3. 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Abdominal Aortic Aneurysms

Intervention(s)

Device: The Nellix® EndoVascular Aneurysm Sealing System

Primary Outcome(s)

Safety- Number of Major Adverse Events [Time Frame: 30 day]

Device Performance [Time Frame: 30 days]

Secondary Outcome(s)

All Cause Mortality [Time Frame: 12 months]

Secondary ID(s)

N09-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors