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RECRUITING Not applicable ClinicalTrials.gov

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Sponsor: Endologix • ClinicalTrials.gov ID: NCT05064540

Registry updated: 2026-09-09
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Description

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).

Interventions

  • Alto Abdominal Stent Graft System (Device)
    Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
  • FDA Approved EVAR AAA Graft Systems (Device)
    FDA approved comparator of choice

Eligibility criteria

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.

Conditions

AAA AAA - Abdominal Aortic Aneurysm

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record