EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Key facts
- Where
- Albuquerque, Bay City, Boston, Camden, Champaign, Cleveland, Colorado Springs, Columbia, Elk Grove Village, Falls Church, Huntsville, Indianapolis, Kansas City, Kingsport, Los Angeles, Memphis, Miami, New York, Orlando, Pensacola, Portland, San Diego, Spokane, Tulsa, Washington D.C., Wausau, and Willoughby, United StatesSee the 27 sites
Where in United States
- New Mexico Heart InstituteAlbuquerque, United StatesNo longer taking part
- McLaren-Bay RegionBay City, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- The Cooper Health SystemCamden, United StatesNo longer taking part
- Christie ClinicChampaign, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesNo longer taking part
- UC Health Memorial HospitalColorado Springs, United StatesNo longer taking part
- Palmetto Health- University of South CarolinaColumbia, United StatesNo longer taking part
- AMITA HealthElk Grove Village, United StatesNo longer taking part
- Inova Research CenterFalls Church, United StatesNo longer taking part
- Valley Vascular ConsultantsHuntsville, United StatesNo longer taking part
- St. Vincent Heart Center of IndianaIndianapolis, United StatesNo longer taking part
- Midwest Aortic & Vascular InstituteKansas City, United StatesNo longer taking part
- Wellmont CVA Heart InstituteKingsport, United StatesNo longer taking part
- Regents of the University of California (UCLA)Los Angeles, United StatesNo longer taking part
- Cardiovascular Surgery ClinicMemphis, United StatesNo longer taking part
- Miami Cardiac & Vascular Institute (MCVI)Miami, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
- AdventHealth OrlandoOrlando, United StatesNo longer taking part
- Coastal Vascular & InterventionalPensacola, United StatesNo longer taking part
- Providence St. Vincent Medical CenterPortland, United StatesNo longer taking part
- Veterans Medical Research FoundationSan Diego, United StatesNo longer taking part
- Providence Sacred Heart Medical CenterSpokane, United StatesNo longer taking part
- OU College of MedicineTulsa, United StatesNo longer taking part
- Medstar Health Research InstituteWashington D.C., United StatesNo longer taking part
- Aspirus Research InstituteWausau, United StatesNo longer taking part
- Northeast Ohio Vascular Assoc (NEOVA)Willoughby, United StatesNo longer taking part
Trial details
- Who runs it
- Endologix
- Trial code
- NCT03298477
- Record updated
- 19 May 2026
- Original description
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.Read full original descriptionShow less
Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)
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.
Inclusion: 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.
Exclusion: Psychiatric or other condition that may interfere with the study; Known allergy or contraindication to any device material; Coagulopathy or uncontrolled bleeding disorder; Aneurysmal disease of the descending thoracic aorta; Connective tissue diseases (e.g., Marfan Syndrome); Serum creatinine (S-Cr) level >2.0 mg/dL; Life expectancy <2 years as judged by the Investigator; A patient who meets none of the following criteria potentially may be included in the study:; Participating in another clinical study; Ruptured, leaking or mycotic aneurysm; CVA or MI within three months of enrollment/treatment; Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference); Unsuitable vascular anatomy that may interfere with device introduction or deployment; Pregnant (female of childbearing potential only).