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ACTIVE NOT RECRUITING
NCT03298477
NA

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

Sponsor: Endologix

View on ClinicalTrials.gov

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

DEVICE

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