JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Last updated: June 5, 2025
Sponsor: Endologix
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Aneurysm

Cardiovascular Disease

Treatment

Alto Abdominal Stent Graft System

FDA Approved EVAR AAA Graft Systems

Clinical Study ID

NCT05064540
CP-0017
  • Ages > 21
  • All Genders

Study 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

Inclusion

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 beeligible 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

Exclusion Criteria:

  • Currently participating in another trial where the primary endpoint has not beenreached 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 apreviously failed EVAR.

  • Patient has other medical, social, or psychological conditions that, in the opinionof the investigator, preclude them from receiving the pre-treatment, requiredtreatment, and post-treatment procedures and evaluations.

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Alto Abdominal Stent Graft System
Phase:
Study Start date:
September 20, 2021
Estimated Completion Date:
March 31, 2031

Connect with a study center

  • Huntsville Hospital

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85716
    United States

    Active - Recruiting

  • Washington Regional Medical Center

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • The Regents of the University of California, San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Veterans Affairs San Diego Healthcare System

    San Diego, California 92161
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20001
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Radiology and Imaging Specialists

    Lakeland, Florida 33801
    United States

    Active - Recruiting

  • Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

    Miami, Florida 33176
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202-1959
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029-6574
    United States

    Active - Recruiting

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

    Staten Island, New York 10305
    United States

    Active - Recruiting

  • The Cleveland Clinical Foundation

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Wellmont Cardiology Services

    Kingsport, Tennessee 37660
    United States

    Active - Recruiting

  • The University of Texas Medical Branch at Galveston

    Galveston, Texas 77555
    United States

    Active - Recruiting

  • Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Sentara Hospitals

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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