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Active Clinical Trials

CP-0008

Active NCT:
01726257
Allegheny General Hospital
Allegheny General Hospital

Allegheny Valley Hospital
Allegheny Valley Hospital

Forbes Hospital
Forbes Hospital

Peters Township Health + Wellness Pavilion
Peters Township Health + Wellness Pavilion

Sponsor: 
Endologix, Inc.
Contact: 

For more information, please contact Sheila Bernardini at 412-359-3281 or Sheila.Bernardini@ahn.org

CP-0008: Prospective, Multicenter, Single Arm 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).

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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 ≥5.5cm, 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 16 to 32mm; angle ≤60° to the aneurysm sac;
  • Common iliac artery lumen diameter between 8 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 > 2.0 mg/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).