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

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Trial Conditions
  • Abdominal Aortic Aneurysm (AAA)
What is the purpose of this trial?

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).

Date & Status

Not yet recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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 >2.0mg/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).

Gender: Both
Steward Physician(s)
  • Jeffrey Carpenter, MD
Trial Interventions
Device
  • Nellix System
Physician Researcher

Investigator Name:

  • Jeffrey Carpenter, MD

Other Information

Sponsor: Endologix
Phase: N/A
Trial ID: NCT01726257
Volunteers:  Not Accepting Healthy Volunteers

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