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EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Sponsor: Endologix
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2017-12-01
Completion Date
2025-08-16
Last Updated
2025-03-19
Healthy Volunteers
No
Interventions
Nellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Locations (27)
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
Providence Sacred Heart Medical Center
Spokane, Washington, United States
Aspirus Research Institute
Wausau, Wisconsin, United States