EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysm Without Rupture

In brief

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Key facts

Study ID

NCT03298477

Run by

Endologix

People needed

98

Starts

2017-12-01

Expected to finish

2025-08-16

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient who meets all of the following criteria potentially may be included in the study:
• Male or female at least 18 years old;
• Informed consent form understood and signed
• Patient agrees to all follow-up visits;
• Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
• Anatomically eligible for the Nellix System (per Instructions For Use):
• Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
• Aneurysm blood lumen diameter ≤60mm;
• Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
• Most caudal renal artery to each hypogastric artery length ≥100mm;
• Common iliac artery lumen diameter between 9 and 35mm;
• Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
• Ability to preserve at least one hypogastric artery.
• Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40

You may not qualify if…

• A patient who meets none of the following criteria potentially may be included in the study:
• Life expectancy <2 years as judged by the Investigator;
• Psychiatric or other condition that may interfere with the study;
• Participating in another clinical study;
• Known allergy or contraindication to any device material;
• Coagulopathy or uncontrolled bleeding disorder;
• Ruptured, leaking or mycotic aneurysm;
• Serum creatinine (S-Cr) level >2.0 mg/dL;
• CVA or MI within three months of enrollment/treatment;
• Aneurysmal disease of the descending thoracic aorta;
• Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
• Connective tissue diseases (e.g., Marfan Syndrome);
• Unsuitable vascular anatomy that may interfere with device introduction or deployment;
• Pregnant (female of childbearing potential only).

Where it is running

• Valley Vascular Consultants — Huntsville, Alabama, United States
• Regents of the University of California (UCLA) — Los Angeles, California, United States
• Veterans Medical Research Foundation — San Diego, California, United States
• UC Health-Memorial Hospital — Colorado Springs, Colorado, United States
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• Miami Cardiac & Vascular Institute (MCVI) — Miami, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Coastal Vascular & Interventional — Pensacola, Florida, United States
• Christie Clinic — Champaign, Illinois, United States
• AMITA Health — Elk Grove Village, Illinois, United States
• St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• McLaren Bay Region — Bay City, Michigan, United States
• Midwest Aortic & Vascular Institute — Kansas City, Missouri, United States
• The Cooper Health System — Camden, New Jersey, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Northeast Ohio Vascular Assoc (NEOVA) — Willoughby, Ohio, United States
• OU College of Medicine — Tulsa, Oklahoma, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Palmetto Health- University of South Carolina — Columbia, South Carolina, United States
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States
• Cardiovascular Surgery Clinic — Memphis, Tennessee, United States
• Inova Research Center — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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