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JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization | Clinical Trials | Clareo Health

RECRUITINGNA

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

NCT05064540•Endologix

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (29)

Huntsville Hospital

Huntsville, Alabama, United States

University of Arizona

Tucson, Arizona, United States

Washington Regional Medical Center

Fayetteville, Arkansas, United States

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

The Regents of the University of California, San Diego

La Jolla, California, United States

Veterans Affairs San Diego Healthcare System

San Diego, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Radiology and Imaging Specialists

Lakeland, Florida, United States

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, United States

Key Dates

Start Date

September 20, 2021

Primary Completion Date

March 1, 2031

Completion Date

March 1, 2031

Last Updated

June 8, 2025

Enrollment

450

ESTIMATED participants

Conditions

AAAAAA - Abdominal Aortic Aneurysm

Interventions

Alto Abdominal Stent Graft System

DEVICE

FDA Approved EVAR AAA Graft Systems

DEVICE

Contacts

Noel DeSisto

CONTACT

864-270-8524 ndesisto@endologix.com

Sanjana Tabassum

CONTACT

stabassum@endologix.com

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

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Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

NCT06884397

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Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Inclusion Criteria

Exclusion Criteria

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

Post-operative Quality of Life After AAA Management: EVAR Versus Open Repair

Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence

Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft