Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
Purpose
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).
Condition
- Abdominal Aortic Aneurysm (AAA)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Nellix System |
Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study. |
|
More Details
- Status
- Completed
- Sponsor
- Endologix
Study Contact
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.