JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorEndologix
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Alto Abdominal Stent Graft System
- FDA Approved EVAR AAA Graft Systems
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov