JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Endologix
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).
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 p…
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
Locations (29)
- Huntsville HospitalHuntsville, Alabama
- University of ArizonaTucson, Arizona
- Washington Regional Medical CenterFayetteville, Arkansas
- Central Arkansas Veterans Healthcare SystemLittle Rock, Arkansas
- The Regents of the University of California, San DiegoLa Jolla, California
- Veterans Affairs San Diego Healthcare SystemSan Diego, California