Actively Recruiting
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Led by Endologix · Updated on 2025-06-08
450
Participants Needed
29
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating outcomes of endovascular abdominal aortic aneurysm repair (EVAR) in adults with unruptured infrarenal abdominal aortic aneurysm (AAA). This randomized, multi-center study compares two commercially available devices to understand their performance and safety in a real-world population. The study aims to measure freedom from aneurysm-related complications and neck dilation over a 5-year period. Participants will be randomly assigned to receive either the Endologix Alto Abdominal Stent Graft System or a comparator FDA-approved EVAR device for aneurysm repair. Follow-up occurs during the procedure, at hospital discharge, at 1, 6, and 12 months, then annually up to 5 years. The study tracks device performance and adverse events through this timeline. During the study, participants will undergo clinical evaluations and imaging to monitor aneurysm repair outcomes and device integrity. Researchers will track aneurysm-related complications, mortality, endoleaks, device migration, secondary interventions, and other major adverse events. This long-term follow-up includes yearly visits for up to 5 years after treatment to assess safety and device durability.
CONDITIONS
Brief Title
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult age 21 and older
- Life expectancy of at least 2 years
- Signed informed consent document
- Unruptured infrarenal abdominal aortic aneurysm eligible for endovascular repair with trial devices
- Ability and willingness to comply with all required follow-up exams
You will not qualify if you...
- Currently participating in another trial with ongoing primary endpoint
- Known allergy to any device components
- Pregnant females of childbearing potential
- Known connective tissue disorders
- Known active infection
- Previous endovascular aneurysm repair needing repair or intervention
- Medical, social, or psychological conditions preventing required procedures or evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Single procedure
Participants undergo implantation of the assigned endovascular abdominal aneurysm repair (EVAR) device to repair the abdominal aortic aneurysm.
1 implantation visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety and effectiveness of the implanted device, including assessment of aneurysm-related complications and device integrity.
Visits at 30 days, 12 months, and annually up to 5 years
Trial Site Locations
Total: 29 locations
1
Huntsville Hospital
Huntsville, Alabama, United States, 35801
Active, Not Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85716
Actively Recruiting
3
Washington Regional Medical Center
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
4
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
Actively Recruiting
5
The Regents of the University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
6
Veterans Affairs San Diego Healthcare System
San Diego, California, United States, 92161
Actively Recruiting
7
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20001
Actively Recruiting
8
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
9
Radiology and Imaging Specialists
Lakeland, Florida, United States, 33801
Actively Recruiting
10
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
Miami, Florida, United States, 33176
Actively Recruiting
11
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
12
University of Louisville
Louisville, Kentucky, United States, 40202-1959
Actively Recruiting
13
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
14
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Withdrawn
15
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
16
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
17
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
Actively Recruiting
18
Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)
Staten Island, New York, United States, 10305
Actively Recruiting
19
The Cleveland Clinical Foundation
Cleveland, Ohio, United States, 44106
Actively Recruiting
20
The Ohio State University
Columbus, Ohio, United States, 43210
Withdrawn
21
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
22
U.S. Department of Veterans Affairs, VA Portland Health Care System
Portland, Oregon, United States, 97239
Actively Recruiting
23
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
24
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
26
Wellmont Cardiology Services
Kingsport, Tennessee, United States, 37660
Actively Recruiting
27
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
Actively Recruiting
28
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
29
Sentara Hospitals
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
N
Noel DeSisto
S
Sanjana Tabassum
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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