Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
Completed · Not applicable
Conditions studied: Abdominal Aortic Aneurysm (AAA)
In brief
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).
Key facts
- Study ID
- NCT01726257
- Run by
- Endologix
- People needed
- 333
- Starts
- 2013-12-01
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2025-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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).
Where it is running
- Tucson Medical Center — Tucson, Arizona, United States
- VA San Diego — San Diego, California, United States
- Yale University — New Haven, Connecticut, United States
- Christiana Care Hospital — Newark, Delaware, United States
- MedStar Health Research Institute — Washington D.C., District of Columbia, United States
- Baptist Hospital of Miami — Miami, Florida, United States
- Sacred Heart — Pensacola, Florida, United States
- St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States
- Maine Medical Center — Portland, Maine, United States
- St. Elizabeth's Medical Center — Brighton, Massachusetts, United States
- Bay State Hospital — Springfield, Massachusetts, United States
- Spectrum Health — Grand Rapids, Michigan, United States
- Minneapolis Hospital — Minneapolis, Minnesota, United States
- St. Vincent Heart and Vascular Center of Montana — Billings, Montana, United States
- Nebraska Heart Institute — Lincoln, Nebraska, United States
- Cooper Hospital — Camden, New Jersey, United States
- Carolinas Health Care — Charlotte, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Ohio Health Research Institute — Columbus, Ohio, United States
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- UPMC Heart and Vascular Institue — Pittsburgh, Pennsylvania, United States
- St. Luke's Medical Center — Houston, Texas, United States
- The Heart Hospital Baylor Plano — Plano, Texas, United States
- Scott & White Healthcare System — Temple, Texas, United States
- Inova Fairfax Hospital — Falls Church, Virginia, United States
Full record on ClinicalTrials.gov
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