Evaluating outcomes of endovascular abdominal aortic aneurysm repair
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
This study is testing two different devices for repairing abdominal aortic aneurysms to see which one works better for patients over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Endologix Industry-sponsored |
| Locations | 29 sites (Huntsville, Alabama and 28 other locations) |
| Trial ID | NCT05064540 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized, multi-center study aims to assess the outcomes of contemporary endovascular abdominal aortic aneurysm (EVAR) devices in a real-world population. Patients will be randomly assigned to two different device cohorts and their outcomes will be compared across primary endpoints. Follow-up evaluations will occur at discharge, and at 1, 6, 12 months, and annually for up to 5 years to monitor long-term results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with unruptured infrarenal abdominal aortic aneurysms who are eligible for endovascular repair.
Not a fit: Patients currently participating in another trial or those with known allergies to device components may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with abdominal aortic aneurysms.
How similar studies have performed: Other studies have shown success with similar randomized approaches in evaluating EVAR outcomes, indicating a promising avenue for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Huntsville, Alabama and 28 other locations
- Huntsville Hospital — Huntsville, Alabama, United States (Active_not_recruiting)
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- Washington Regional Medical Center — Fayetteville, Arkansas, United States (Recruiting)
- Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States (Recruiting)
- The Regents of the University of California, San Diego — La Jolla, California, United States (Recruiting)
- Veterans Affairs San Diego Healthcare System — San Diego, California, United States (Recruiting)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
- Radiology and Imaging Specialists — Lakeland, Florida, United States (Recruiting)
- Baptist Hospital of Miami, Miami Cardiac and Vascular Institute — Miami, Florida, United States (Recruiting)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Active_not_recruiting)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Hospital — Detroit, Michigan, United States (Withdrawn)
- University of Missouri — Columbia, Missouri, United States (Recruiting)
- Newark Beth Israel Medical Center — Newark, New Jersey, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health) — Staten Island, New York, United States (Recruiting)
- The Cleveland Clinical Foundation — Cleveland, Ohio, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Withdrawn)
- Oregon Health Sciences University — Portland, Oregon, United States (Recruiting)
- U.S. Department of Veterans Affairs, VA Portland Health Care System — Portland, Oregon, United States (Recruiting)
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Recruiting)
- Wellmont Cardiology Services — Kingsport, Tennessee, United States (Recruiting)
- The University of Texas Medical Branch at Galveston — Galveston, Texas, United States (Recruiting)
- Houston Methodist Research Institute — Houston, Texas, United States (Recruiting)
- Sentara Hospitals — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Sean Lyden, MD — The Cleveland Clinic
- Study coordinator: Noel DeSisto
- Email: ndesisto@endologix.com
- Phone: 864-270-8524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.