Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 333
- Locations
- 60
- Primary Endpoint
- Major Adverse Events at 30 Days
Study Overview
Brief Summary
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Major Adverse Events at 30 Days
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported