JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Launched by ENDOLOGIX · Sep 30, 2021

Keywords

ClinConnect Summary

The JAGUAR Trial is a research study looking at the effectiveness of new devices used to treat a condition called Abdominal Aortic Aneurysm (AAA). This condition involves a bulge in the aorta, the large blood vessel that supplies blood to the body, which can be very serious if it ruptures. In this trial, eligible participants will be randomly assigned to receive one of two different types of devices used for a procedure called endovascular repair, which is a less invasive way to fix the aneurysm. Researchers want to see how well these devices work in real-life situations over time.

To be part of the study, participants must be adults aged 21 or older with an unruptured AAA and a life expectancy of at least two years. They should also be able to attend follow-up appointments after the procedure. Participants will be monitored closely right after the procedure, and then again at 1, 6, and 12 months, and annually for up to five years. This study is currently recruiting, and it’s important to note that individuals with certain conditions or who are pregnant cannot participate. Joining this trial means contributing to important research that could help improve treatment options for AAA in the future.

Gender

ALL

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.