Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

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 outcomes generalizability. 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.

• Nellix System (Device): Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.

Primary outcomes

• Major Adverse Events at 30 Days [30 days]: Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
• Treatment Success at 1 Year [1 year]: 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.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Male or female at least 18 years old;
* Informed consent understood and signed;
* Patient agrees to all follow-up visits;
* Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
* Anatomic eligibility for the Nellix System per the instructions for use:
* Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
* Aneurysm blood lumen diameter ≤60mm;
* Most caudal renal artery to aortoiliac bifurcation length ≥100mm;
* Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac;
* Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm;
* Ability to preserve at least one hypogastric artery.

Exclusion Criteria:

* Life expectancy <2 years;
* Psychiatric or other condition that may interfere with the study;
* Participating in enrollment of another clinical study
* Known allergy to device any device component;
* Coagulopathy or uncontrolled bleeding disorder;
* Ruptured, leaking or mycotic aneurysm;
* Serum creatinine level >2.0mg/dL;
* CVA or MI within three months of enrollment/treatment;
* Aneurysmal disease of the descending thoracic aorta;
* Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference);
* Connective tissue diseases (e.g., Marfan Syndrome)
* Unsuitable vascular anatomy;
* Pregnant (females of childbearing potential only).

Participant flow

Outcome results

• Major Adverse Events at 30 Days (Primary), Count of participants, Participants: Pivotal Cohort 4; Roll-In Cohort 1; Continued Access Cohort 2
• Treatment Success at 1 Year (Primary), Count of participants, Participants: Pivotal Cohort (ITT) 126; Roll-In Cohort 22; Continued Access Cohort 94

Adverse events

Time frame: All serious and non-serious events within 30 days, at 6 months, and annually to 5 years

Serious adverse events by term

Other adverse events by term

• Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K. Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91. PMID 22885361
• Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15. PMID 21497521
• Results publication: Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Hashemi H, Cuff R; Nellix Investigators. Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results. J Vasc Surg. 2020 Sep;72(3):918-930.e2. doi: 10.1016/j.jvs.2019.11.039. Epub 2020 Feb 5. PMID 32035772
• Results publication: Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Buckley CJ, Hashemi H, Cuff R; Nellix Investigators. Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial. J Vasc Surg. 2018 Sep;68(3):720-730.e1. doi: 10.1016/j.jvs.2018.01.031. Epub 2018 Mar 31. PMID 29609994
• Results publication: Carpenter JP, Cuff R, Buckley C, Healey C, Hussain S, Reijnen MM, Trani J, Bockler D; Nellix Investigators. Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing. J Vasc Surg. 2016 Jan;63(1):23-31.e1. doi: 10.1016/j.jvs.2015.07.096. Epub 2015 Oct 21. PMID 26482997

• Study Protocol and Statistical Analysis Plan (PDF, 2018-04-06)

• Jeffrey Carpenter, MD, Principal investigator, Cooper Hospital, Camden, NJ