JAGUAR
Trial Overview
Official Title
ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Study Purpose
The objective of this post-approval, randomized, controlled study is to collect additional safety, performance and effectiveness data on Alto Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms and evaluate real-world outcomes in comparison to commercially available comparator devices.
Diagnosis
Unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.Eligibility
- 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 posttreatment procedures and evaluations
Intervention
Endologix (Alto) Graft versus
Medtronic Endurant System versus
Gore Excluder System versus
Cook Zenith System
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Key Participation Requirements
Trial Location(s)
Gender
Male or Female
Age
19-80
Enrollment Status
Recruiting
Phase
Not Applicable
Methodist Health System Trial Code
NCT05064540