Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System (EVAS1)

Endologix

Status

Completed

Conditions

Abdominal Aortic Aneurysm (AAA)

Treatments

Device: Nellix System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01726257

CP-0008

Details and patient eligibility

About

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Full description

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.

Enrollment

333 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).