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JAGUAR Trial: Evaluating EVAR for Abdominal Aortic Aneurysms

This study, called the JAGUAR Trial, is looking at how well two different types of stent grafts work for treating abdominal aortic aneurysms (AAA). An AAA is a bulge in the main artery that carries blood from your heart to the rest of your body. You would receive either the Alto Abdominal Stent Graft System or another FDA-approved EVAR AAA Graft System. Researchers want to see how many people avoid aneurysm-related complications and how much the neck of the aneurysm changes over five years. This study is for adults aged 21 and older with an unruptured AAA who are healthy enough for surgery and can commit to follow-up appointments. The current status of this study is unclear.

Study design
This is a prospective, randomized, multi-center study aiming to enroll 450 participants. Participants will be randomly assigned to one of two device groups.
What's involved
You would have follow-up appointments from discharge, at 1, 6, and 12 months, and then yearly for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to monitor for aneurysm-related complications and neck dilation.

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NCT05064540

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Recruiting
NAAges 21+InterventionalTreatment
Endologix
~450 participants
Updated 2025-06-08 on ClinicalTrials.gov
What's tested:Alto Abdominal Stent Graft SystemFDA Approved EVAR AAA Graft Systems

At a glance

Recruiting sites
25 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Freedom from Aneurysm-Related Complications (ARC)
Measured over Through 5 years
+1 more outcome measured

Conditions

AAA
AAA - Abdominal Aortic Aneurysm

Explore related trials

Abdominal Aortic Aneurysm

Where it's being run

29 sites across 19 states
Florida3
Pennsylvania3
Arkansas2
California2
New York2
Ohio2
Oregon2
Texas2

Study leadership

  • Sean Lyden, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
  • Christopher Kwolek, MD · PRINCIPAL_INVESTIGATOR · Newton-Wellesley Hospital
  • Hence Verhagen, MD, PhD · PRINCIPAL_INVESTIGATOR · Erasmus University Study Center

Who to contact

Noel DeSisto
[email protected]
864-270-8524
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Freedom from Aneurysm-Related Complications (ARC)Through 5 years

    Composite endpoint consisting of aneurysm-related death, aneurysm rupture, conversion to open surgery, type I and III endoleaks, device migration (\>10mm), aneurysm sac enlargement (\>5mm), occlusion, and freedom from device-related interventions

  • Neck Dilation in mmThrough 5 years