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NCT05064540NARecruiting

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Endologix

Start Date

9/20/2021

Completion Date

3/1/2031

Summary

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

Eligibility Criteria

Age Range: 21 years to No maximum

Inclusion Criteria: * Adult age 21 and older * Subjects with minimum of 2 year life expectancy * Subjects have signed the informed consent document * Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices. * Patient must be able and willing to comply with all required follow-up exams. Exclusion Criteria: * Currently participating in another trial where the primary endpoint has not been reached yet. * Known allergy to any of the device components * Pregnant (females of childbearing potential only) * Known connective tissue disorders * Known active infection * Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR. * Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Interventions

DEVICE

Alto Abdominal Stent Graft System

DEVICE

FDA Approved EVAR AAA Graft Systems

Interested in This Trial?

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Conditions

AAAAAA - Abdominal Aortic Aneurysm

Locations

Huntsville Hospital

Huntsville, Alabama 35801

United States

University of Arizona

Tucson, Arizona 85716

United States

Washington Regional Medical Center

Fayetteville, Arkansas 72703

United States

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas 72205

United States

The Regents of the University of California, San Diego

La Jolla, California 92093

United States

Veterans Affairs San Diego Healthcare System

San Diego, California 92161

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20001

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Radiology and Imaging Specialists

Lakeland, Florida 33801

United States

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida 33176

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

University of Louisville

Louisville, Kentucky 40202-1959

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

University of Missouri

Columbia, Missouri 65212

United States

Newark Beth Israel Medical Center

Newark, New Jersey 07112

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029-6574

United States

Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)

Staten Island, New York 10305

United States

The Cleveland Clinical Foundation

Cleveland, Ohio 44106

United States

The Ohio State University

Columbus, Ohio 43210

United States

Oregon Health Sciences University

Portland, Oregon 97239

United States

U.S. Department of Veterans Affairs, VA Portland Health Care System

Portland, Oregon 97239

United States

Lehigh Valley Health Network

Allentown, Pennsylvania 18103

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States

Wellmont Cardiology Services

Kingsport, Tennessee 37660

United States

The University of Texas Medical Branch at Galveston

Galveston, Texas 77555

United States

Houston Methodist Research Institute

Houston, Texas 77030

United States

Sentara Hospitals

Norfolk, Virginia 23507

United States