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

a study on Aneurysm

Summary

for people ages 18 years and up (full criteria)
at San diego, California and other locations
study started
estimated completion:

Description

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).

Official Title

Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study

Details

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.

Keywords

Abdominal Aortic Aneurysm (AAA) Infrarenal Abdominal Aortic Aneurysm AAA Endologix EVAS EndoVascular Sealing System Aortic Aneurysm Aortic Aneurysm, Abdominal Nellix System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).

Locations

  • VA San Diego accepting new patients
    San diego California 92161 United States
  • Tucson Medical Center accepting new patients
    Tucson Arizona 85712 United States
  • St. Vincent Heart and Vascular Center of Montana accepting new patients
    Billings Montana 59101 United States
  • Providence Sacred Heart Medical Center accepting new patients
    Spokane Washington 99204 United States
  • Scott & White Healthcare System accepting new patients
    Temple Texas 76508 United States
  • The Heart Hospital Baylor Plano accepting new patients
    Plano Texas 75093 United States
  • Nebraska Heart Institute accepting new patients
    Lincoln Nebraska 68526 United States
  • St. Luke's Medical Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Endologix
ID
NCT01726257
Study Type
Interventional
Last Updated
October 2016