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Recruiting NCT05064540

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Conditions: AAA, AAA - Abdominal Aortic Aneurysm

Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 450
Sponsor: Endologix

Location: Huntsville Hospital Huntsville Alabama

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05064540). StuddyBuddy aggregates publicly available trial information.