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

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

ArmDescriptionAssigned Intervention
Experimental
Nellix System
The Nellix EndoVascular Aneurysm Sealing System ( Nellix System ) will be implanted into patients with an infrarenal abdominal aortic aneurysm (AAA).
  • Device: Nellix System
    Other names:
    • Nellix Endovascular Aneurysm Sealing System

Recruiting Locations

MedStar Health Research Institute
Washington, District of Columbia 20010
Contact:
Suman Singh
202-877-8475
Suman.Singh@Medstar.net

More Details

Status
Recruiting
Sponsor
Endologix

Study Contact

Peter Miller
949-595-7200
pmiller@endologix.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.