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AAANCT05409118

JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization

A study testing Alto Abdominal Stent Graft System and FDA Approved EVAR AAA Graft Systems in people with AAA and AAA - Abdominal Aortic Aneurysm, run by Endologix.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
AAA, AAA - Abdominal Aortic Aneurysm
What is being tested?
Alto Abdominal Stent Graft System and FDA Approved EVAR AAA Graft Systems
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2025to Dec 2030
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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).

Being tested
Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alto Abdominal Stent Graft SystemDevice

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

  • FDA Approved EVAR AAA Graft SystemsDevice

    Also called Medtronic Endurant, Cook Zenith, Gore Excluder

    FDA approved comparator of choice

Study groups in NCT05409118
Study groupRoleWhat they receive
Alto Abdominal Stent Graft SystemExperimentalSubjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
Receives: Device: Alto Abdominal Stent Graft System
ComparatorsActive comparatorSubjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.
Receives: Device: FDA Approved EVAR AAA Graft Systems

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through 5 Years

  2. Neck Dilation in mm

    Measured: Through 5 Years

Secondary outcomes (18)

  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

    Measured: [Time Frame: At 30 days and 12 months]

  2. Count of participants All Cause Mortality

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

  3. Count of participants AAA-related Mortality

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

  4. Number of Type Ia endoleaks

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

  5. Number of Type Ib

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

  6. Number of Type II

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

  7. Number of Type III

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

  8. Number of Type IV

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

  9. Number of Unknown Enooleaks

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

  10. Number of Secondary interventions

    Measured: 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)

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

  12. Count of aneurysm ruptures

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

  13. Count of participants with conversion to open surgery

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

  14. Count of participants with type I and III endoleaks

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

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

    Measured: 12 months, and annually up to five years

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

    Measured: 12 months, and annually up to five years

  17. Count of subjects with occlusion

    Measured: 30 days, 12 months, and annually up to five years]

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

    Measured: 30 days, 12 months, and annually up to five years]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Why it stopped: This is an EU protocol, and as a company, it was decided to only enroll within the US so this protocol/study is being withdrawn.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409118
Sponsor's protocol ID
CP-0022
Status last verified
Aug 2025
First submitted
3 Jun 2022
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared with others

Questions about this trial

What is this clinical trial studying?

A study testing Alto Abdominal Stent Graft System and FDA Approved EVAR AAA Graft Systems in people with AAA and AAA - Abdominal Aortic Aneurysm, run by Endologix.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Freedom from Aneurysm-Related Complications (ARC) (time frame: Through 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05409118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

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