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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

  1. Currently participating in another trial where the primary endpoint has not been reached yet
  2. Known allergy to any of the device components
  3. Pregnant (females of childbearing potential only)
  4. Known connective tissue disorders
  5. Known active infection
  6. Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR.
  7. 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

For more information, click the link below:

https://clinicaltrials.gov/study/NCT05064540

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
Related Specialties