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RecruitingNCT05064540JAGUARUpdated Sep 9, 2026

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

An interventional study of Alto Abdominal Stent Graft System and FDA Approved EVAR AAA Graft Systems in AAA and AAA - Abdominal Aortic Aneurysm, sponsored by Endologix. Recruiting at 29 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Endologix · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

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).

02

Conditions studied

  • AAA
  • AAA - Abdominal Aortic Aneurysm

Keywords

  • randomized
03

In context

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's planned enrollment of 450 is above the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Endologix is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 9 (82%) have results posted.

Browse Endologix studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult age 21 and older
  • Subjects with minimum of 2 year
  • Subjects have signed the 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

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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    Alto Abdominal Stent Graft System

    Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.

    Device: Alto Abdominal Stent Graft System

  • Active comparator
    Comparators

    Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.

    Device: FDA Approved EVAR AAA Graft Systems

Interventions

  • DeviceAlto Abdominal Stent Graft System

    Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.

  • DeviceFDA Approved EVAR AAA Graft Systems

    FDA approved comparator of choice

06

What researchers measure

Primary outcomes

  1. Number of Participants with Freedom from Aneurysm-Related Complications (ARC)

    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

    Time frame: Through 5 years

  2. Neck Dilation in mm

    Time frame: Through 5 years

Secondary outcomes

  1. Number of Major Adverse Events (MAEs)

    All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL

    Time frame: At 30 days and 12 months

  2. Count of participants All Cause Mortality

    Time frame: At 30 days, 12 months, and annually up to five years

  3. Count of participants AAA-related Mortality

    Time frame: At 30 days, 12 months, and annually up to five years

  4. Number of Type Ia endoleaks

    Time frame: At 30 days, 12 months, and annually up to five years

  5. Number of Type Ib

    Time frame: At 30 days, 12 months, and annually up to five years

  6. Number of Type II

    Time frame: At 30 days, 12 months, and annually up to five years

  7. Number of Type III

    Time frame: At 30 days, 12 months, and annually up to five years

  8. Number of Type IV

    Time frame: At 30 days, 12 months, and annually up to five years

  9. Number of Unknown Enooleaks

    Time frame: At 30 days, 12 months, and annually up to five years

  10. Number of Secondary interventions

    Time frame: At 30 days, 12 months, and annually up to five years

  11. Count of subjects lacking device integrity

    device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak)

    Time frame: At 30 days, 12 months, and annually up to five years

  12. count of aneurysm ruptures

    Time frame: At 30 days, 12 months, and annually up to five years

  13. Count of participants with conversion to open surgery

    Time frame: At 30 days, 12 months, and annually up to five years

  14. Count of participants with type I and III endoleaks

    Time frame: At 30 days, 12 months, and annually up to five years

  15. Count of participants with device migration (>10mm)

    Time frame: 12 months, and annually up to five years

  16. Count of participants with aneurysm sac enlargement (>5mm)

    Time frame: 12 months, and annually up to five years

  17. Count of subjects with occlusion

    Time frame: 30 days, 12 months, and annually up to five years

  18. Number of Participants with Freedom From device-related interventions

    Time frame: 30 days, 12 months, and annually up to five years

07

Study locations

25 of 29 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with others.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2021 (actual). Primary completion is estimated for Mar 2032, 126 months after the start.

Of 43 industry-sponsored interventional studies with no phase under Aortic Aneurysm, Abdominal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 65. This study's planned 126 months is above that.

Counting every sponsor, half of 94 studies reached it within 43 months; a quarter within 23 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2021
First posted
Oct 1, 2021
StartActual
Sep 20, 2021
Primary completionEst.
Mar 2032
CompletionEst.
Mar 2032
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05064540
Lead sponsor
Endologix
Responsible party
Sponsor
First posted
Oct 1, 2021
Start date
Sep 20, 2021
Primary completion
Mar 2032 (estimated)
Completion
Mar 2032 (estimated)
Last update
Sep 9, 2026

Study contacts

Noel DeSisto
Contact
ndesisto@endologix.com
864-270-8524
Sanjana Tabassum
Contact
stabassum@endologix.com
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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