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NCT Number: NCT05064540

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

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).

Recruiting

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Key information

Conditions

AAA AAA - Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsville Hospital, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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 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.

Treatment and study plan

Alto Abdominal Stent Graft System

Device

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

FDA Approved EVAR AAA Graft Systems

Device

FDA approved comparator of choice

Primary outcomes

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

    Time frame: 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

  2. Neck Dilation in mm

    Time frame: Through 5 years

Secondary outcomes

  1. Number of Major Adverse Events (MAEs)

    Time frame: At 30 days and 12 months

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

  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

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

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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Noel DeSisto

CONTACT

[email protected]

864-270-8524

Sanjana Tabassum

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Acronym: JAGUAR

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Oct 1, 2021
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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