RecruitingNot ApplicableNCT05064540

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Sponsor

Endologix

Enrollment

450 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

AAA - Abdominal Aortic Aneurysm AAA

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Alto Abdominal Stent Graft System and a medical device called FDA Approved EVAR AAA Graft Systems for people with aaa and aaa - abdominal aortic aneurysm. The study is currently recruiting participants at 29 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlto Abdominal Stent Graft System

Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.

DEVICEFDA Approved EVAR AAA Graft Systems

FDA approved comparator of choice

Locations(29)

Huntsville Hospital

Huntsville, Alabama, United States

University of Arizona

Tucson, Arizona, United States

Washington Regional Medical Center

Fayetteville, Arkansas, United States

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

The Regents of the University of California, San Diego

La Jolla, California, United States

Veterans Affairs San Diego Healthcare System

San Diego, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Radiology and Imaging Specialists

Lakeland, Florida, United States

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Louisville

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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

Staten Island, New York, United States

The Cleveland Clinical Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health Sciences University

Portland, Oregon, United States

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

Portland, Oregon, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Wellmont Cardiology Services

Kingsport, Tennessee, United States

The University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Houston Methodist Research Institute

Houston, Texas, United States

Sentara Hospitals

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05064540

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