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

Endologix

Status

Completed

Conditions

Abdominal Aortic Aneurysms

Treatments

Device: The Nellix® EndoVascular Aneurysm Sealing System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02048514

N09-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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