JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

NCT05064540 | Recruiting DMC FDA Device

• 1 other identifier: CP-0017
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 29

Brief 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).

Conditions

AAA; AAA - Abdominal Aortic Aneurysm

Keywords

randomized

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Freedom from Aneurysm-Related Complications (ARC)

  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

  Through 5 years

• Neck Dilation in mm

  Through 5 years

Secondary Outcomes (18)

• Number of Major Adverse Events (MAEs)

  At 30 days and 12 months

• Count of participants All Cause Mortality

  At 30 days, 12 months, and annually up to five years

• Count of participants AAA-related Mortality

  At 30 days, 12 months, and annually up to five years

• Number of Type Ia endoleaks

  At 30 days, 12 months, and annually up to five years

• Number of Type Ib

  At 30 days, 12 months, and annually up to five years

Study Arms (2)

Alto Abdominal Stent Graft System

EXPERIMENTAL

Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.

Device: Alto Abdominal Stent Graft System

Comparators

ACTIVE COMPARATOR

Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.

Device: FDA Approved EVAR AAA Graft Systems

Interventions

Alto Abdominal Stent Graft System DEVICE

Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.

Alto Abdominal Stent Graft System

FDA Approved EVAR AAA Graft Systems DEVICE

FDA approved comparator of choice

Comparators

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endologix: lead

Study Sites (29)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

ACTIVE NOT RECRUITING

University of Arizona

Tucson, Arizona, 85716, United States

RECRUITING

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

RECRUITING

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

RECRUITING

The Regents of the University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

Veterans Affairs San Diego Healthcare System

San Diego, California, 92161, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20001, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

Radiology and Imaging Specialists

Lakeland, Florida, 33801, United States

RECRUITING

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

ACTIVE NOT RECRUITING

University of Louisville

Louisville, Kentucky, 40202-1959, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

WITHDRAWN

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

RECRUITING

Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)

Staten Island, New York, 10305, United States

RECRUITING

The Cleveland Clinical Foundation

Cleveland, Ohio, 44106, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

WITHDRAWN

Oregon Health Sciences University

Portland, Oregon, 97239, United States

RECRUITING

U.S. Department of Veterans Affairs, VA Portland Health Care System

Portland, Oregon, 97239, United States

RECRUITING

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Wellmont Cardiology Services

Kingsport, Tennessee, 37660, United States

RECRUITING

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

Sentara Hospitals

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Sean Lyden, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Christopher Kwolek, MD

  Newton-Wellesley Hospital

  PRINCIPAL INVESTIGATOR

• Hence Verhagen, MD, PhD

  Erasmus University Study Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noel DeSisto

CONTACT

864-270-8524; ndesisto@endologix.com

Sanjana Tabassum

CONTACT

stabassum@endologix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 1, 2021
• Study Start: September 20, 2021
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)