JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

NCT05064540 · tracked via the Priya Life Science USA tracker

Sponsor

Endologix

Phase

Not applicable

Started

2021-09-20

Last updated

2026-09-09

Condition(s) studied

AAAAAA - Abdominal Aortic Aneurysm

Investigational drug(s) / intervention(s)

Alto Abdominal Stent Graft SystemFDA Approved EVAR AAA Graft Systems

Alto Abdominal Stent Graft System: Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.

FDA Approved EVAR AAA Graft Systems: FDA approved comparator of choice

Study 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

Sex

ALL

Min age

21 Years

Max age

—

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.

Primary outcome measure(s)

Number of Participants with Freedom from Aneurysm-Related Complications (ARC) — Through 5 years
Composite endpoint consisting of aneurysm-related death, aneurysm rupture, conversion to open surgery, type I and III endoleaks, device migration (\>10mm), aneurysm sac enlargement (\>5mm), occlusion, and freedom from device-related interventions
Neck Dilation in mm — Through 5 years

Trial sites (29)

Facility	City	Region	Status
Huntsville Hospital	Huntsville	Alabama	Active Not Recruiting
University of Arizona	Tucson	Arizona	Recruiting
Washington Regional Medical Center	Fayetteville	Arkansas	Recruiting
Central Arkansas Veterans Healthcare System	Little Rock	Arkansas	Recruiting
The Regents of the University of California, San Diego	La Jolla	California	Recruiting
Veterans Affairs San Diego Healthcare System	San Diego	California	Recruiting
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
Jacksonville Center for Clinical Research	Jacksonville	Florida	Recruiting
Radiology and Imaging Specialists	Lakeland	Florida	Recruiting
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute	Miami	Florida	Recruiting
University of Iowa Hospitals and Clinics	Iowa City	Iowa	Active Not Recruiting
University of Louisville	Louisville	Kentucky	Recruiting
Tufts Medical Center	Boston	Massachusetts	Recruiting
Henry Ford Hospital	Detroit	Michigan	Withdrawn
University of Missouri	Columbia	Missouri	Recruiting
Newark Beth Israel Medical Center	Newark	New Jersey	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)	Staten Island	New York	Recruiting
The Cleveland Clinical Foundation	Cleveland	Ohio	Recruiting
The Ohio State University	Columbus	Ohio	Withdrawn
Oregon Health Sciences University	Portland	Oregon	Recruiting
U.S. Department of Veterans Affairs, VA Portland Health Care System	Portland	Oregon	Recruiting
Lehigh Valley Health Network	Allentown	Pennsylvania	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
Allegheny Health Network	Pittsburgh	Pennsylvania	Recruiting
Wellmont Cardiology Services	Kingsport	Tennessee	Recruiting
The University of Texas Medical Branch at Galveston	Galveston	Texas	Recruiting
Houston Methodist Research Institute	Houston	Texas	Recruiting
Sentara Hospitals	Norfolk	Virginia	Recruiting

More Endologix trials in the USA

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication Active, not recruiting

The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System Active, not recruiting

The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) Enrolling by invitation

Other trials for the same condition

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05064540 on ClinicalTrials.gov ↗ ← All trials in the USA