Recruiting

EVAR OutcomesJAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Sponsor:

Endologix

Code:

NCT05064540

Conditions

AAA

AAA - Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Alto Abdominal Stent Graft System

FDA Approved EVAR AAA Graft Systems

Study Details

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

Study ID

NCT05064540

Start date

Sep 20, 2021

Status verified date

Sep, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alto Abdominal Stent Graft System

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

active comparator: Comparators

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

Interventions

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

Primary outcome measure

Number of Participants with Freedom from Aneurysm-Related Complications (ARC) [ Time Frame: Through 5 years ]
Neck Dilation in mm [ Time Frame: Through 5 years ]

Central Contacts and Locations

Central contacts

Noel DeSisto

864-270-8524 ndesisto@endologix.com

Sanjana Tabassum

stabassum@endologix.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85716

Contacts

Karen Sanchez

kas10@arizona.edu

Principal Investigator:

Wei Zhou, MD

Washington Regional Medical Center

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Callie McQueen

479-463-7858 cmcqueen@wregional.com

Principal Investigator:

Russell Wood

Central Arkansas Veterans Healthcare System

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Sandra Brock

501-257-6906 sandra.brock@va.gov

Principal Investigator:

Lauren Story-Hefta

The Regents of the University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Kathleen Groh

(951)595-2347 kagroh@health.ucsd.edu

Principal Investigator:

Mahmoud Malas, MD

Veterans Affairs San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Annalicia Vargas

annalicia.vargas@va.gov

Principal Investigator:

Ann Gaffey, MD

MedStar Washington Hospital Center

Recruiting

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

Contacts

Kassaye Sesaba

202-877-7452 Kassaye.T.Sesaba@medstar.net

Principal Investigator:

Kyle Reynolds, MD

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Lisa Joseph

904.732.2217 ljoseph@encoredocs.com

Principal Investigator:

Erin Moore, MD

Radiology and Imaging Specialists

Recruiting

Lakeland, Florida, United States, 33801

Contacts

Eve Johnson

863-688-2334 ejohnson@risimaging.com

Principal Investigator:

Fakhir Elmasri, MD

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

David Fernandez

786-596-5392 davidfer@baptisthealth.net

Mikaela Bearham

786-596-4079 MikaelaB@baptisthealth.net

Principal Investigator:

Constantino Pena, MD

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202-1959

Contacts

Leslie Haysley

(502) 852-2801 leslie.haysley@louisville.edu

Principal Investigator:

Amit Dwivedi, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Gaurav Das

617-636-4990 Gaurav.Das@tuftsmedicine.org

Principal Investigator:

Shivani Kumar, MD

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Jennifer Randolph

573-882-4387 Randolphjl@health.missouri.edu

Principal Investigator:

Todd Vogel, MD

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Debra Cook

Debra.cook@rwjbh.org

Principal Investigator:

Bruce Brener, MD

Icahn School of Medicine at Mount Sinai

Recruiting

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

Contacts

Jack Waitz

212-241-8250 Jack.Waitz@mountsinai.org

Principal Investigator:

Sung Yup Kim, MD

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

Recruiting

Staten Island, New York, United States, 10305

Contacts

Alexandra Pantea

718-226-6438 apantea@northwell.edu

Shannen Belotte

718-226-8559 sbelotte@northwell.edu

Principal Investigator:

Kuldeep Singh, MD

The Cleveland Clinical Foundation

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Larissa Schaaf, RN

(216) 445-4437 schaafl@ccf.org

Principal Investigator:

Francis Caputo, Dr.

Oregon Health Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Amie Lorisch

lorischa@ohsu.edu

Principal Investigator:

Cherie Abraham, MD

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

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jin Kim

jin.kim9@va.gov

Rachel Nelson

503-220-8262 rachel.nelson1@va.gov

Principal Investigator:

Matthew Koopmann, MD

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Deborah Mankos

610-402-1635 deborah.mankos@lvhn.org

Principal Investigator:

Benjamin Jackson, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Thomas Hebert

973-454-3066 thomas.hebert@pennmedicine.upenn.edu

Principal Investigator:

Venkat Kalapatapu, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Sheila Bernardini

sheila.bernardini@ahn.org

Principal Investigator:

Satish Muluk, MD

Wellmont Cardiology Services

Recruiting

Kingsport, Tennessee, United States, 37660

Principal Investigator:

Robert Allen, MD

The University of Texas Medical Branch at Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Sana Malik

409-747-7333 sanmalik@utmb.edu

Principal Investigator:

Michael Silva, MD

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Solange Basagoitia

713-441-0176 smbasagoitia@houstonmethodist.org

Principal Investigator:

Alan Lumsden, MD

Sentara Hospitals

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Kara Wiggins, MSN, RN

757-388-7511 KVWIGGIN@sentara.com

Principal Investigator:

Animesh Rathore, MD

More Information

Sponsor

Endologix

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

randomized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Endologix on 2026-09-09.