JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

ID#: NCT05064540

Age: 21 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: September 20, 2021

End Date: December 01, 2028

Contact Information:
Noel DeSisto
864-270-8524
Sanjana Tabassum
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:

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.
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