JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
NCT ID: NCT05064540
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2021-09-20
2031-03-31
Brief Summary
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Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alto Abdominal Stent Graft System
Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
Alto Abdominal Stent Graft System
Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
Comparators
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.
FDA Approved EVAR AAA Graft Systems
FDA approved comparator of choice
Interventions
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Alto Abdominal Stent Graft System
Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
FDA Approved EVAR AAA Graft Systems
FDA approved comparator of choice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Endologix
INDUSTRY
Responsible Party
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Principal Investigators
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Sean Lyden, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Christopher Kwolek, MD
Role: PRINCIPAL_INVESTIGATOR
Newton-Wellesley Hospital
Hence Verhagen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus University Study Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Joshua Lester
Role: primary
Other Identifiers
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CP-0017
Identifier Type: -
Identifier Source: org_study_id
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