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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
ID05064540

JAGUAR Study Comparing Two FDA-Approved Devices for Endovascular Repair of Abdominal Aortic Aneurysm in Adults

Led by Endologix · Updated on 2025-06-08

450

Participants Needed

29

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating outcomes of endovascular abdominal aortic aneurysm repair EVAR in adults with unruptured infrarenal abdominal aortic aneurysm AAA. This randomized, multi-center study compares two commercially available devices to understand their performance and safety in a real-world population. The study aims to measure freedom from aneurysm-related complications and neck dilation over a 5-year period. Participants will be randomly assigned to receive either the Endologix Alto Abdominal Stent Graft System or a comparator FDA-approved EVAR device for aneurysm repair. Follow-up occurs during the procedure, at hospital discharge, at 1, 6, and 12 months, then annually up to 5 years. The study tracks device performance and adverse events through this timeline. During the study, participants will undergo clinical evaluations and imaging to monitor aneurysm repair outcomes and device integrity. Researchers will track aneurysm-related complications, mortality, endoleaks, device migration, secondary interventions, and other major adverse events. This long-term follow-up includes yearly visits for up to 5 years after treatment to assess safety and device durability.

CONDITIONS

Brief Title

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Research Team

N

Noel DeSisto

S

Sanjana Tabassum

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