JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization (JAGUAR)

June 5, 2025 updated by: Endologix

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Active, not recruiting
        • Huntsville Hospital
    • Arizona
      • Tucson, Arizona, United States, 85716
        • Recruiting
        • University of Arizona
        • Principal Investigator:
          • Wei Zhou, MD
        • Contact:
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Washington Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Russell Wood
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Central Arkansas Veterans Healthcare System
        • Contact:
        • Principal Investigator:
          • Lauren Story-Hefta
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • The Regents of the University of California, San Diego
        • Principal Investigator:
          • Mahmoud Malas, MD
        • Contact:
      • San Diego, California, United States, 92161
        • Recruiting
        • Veterans Affairs San Diego Healthcare System
        • Contact:
        • Principal Investigator:
          • Ann Gaffey, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20001
        • Recruiting
        • Medstar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • Kyle Reynolds, MD
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Contact:
        • Principal Investigator:
          • Erin Moore, MD
      • Lakeland, Florida, United States, 33801
        • Recruiting
        • Radiology and Imaging Specialists
        • Principal Investigator:
          • Fakhir Elmasri, MD
        • Contact:
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
        • Principal Investigator:
          • Constantino Pena, MD
        • Contact:
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Active, not recruiting
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202-1959
        • Recruiting
        • University of Louisville
        • Contact:
        • Principal Investigator:
          • Amit Dwivedi, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
        • Principal Investigator:
          • Shivani Kumar, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Withdrawn
        • Henry Ford Hospital
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri
        • Contact:
        • Principal Investigator:
          • Todd Vogel, MD
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
        • Principal Investigator:
          • Bruce Brener, MD
    • New York
      • New York, New York, United States, 10029-6574
        • Recruiting
        • Icahn School Of Medicine At Mount Sinai
        • Principal Investigator:
          • Sung Yup Kim, MD
        • Contact:
      • Staten Island, New York, United States, 10305
        • Recruiting
        • Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kuldeep Singh, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • The Cleveland Clinical Foundation
        • Contact:
        • Principal Investigator:
          • Francis Caputo, Dr.
      • Columbus, Ohio, United States, 43210
        • Withdrawn
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University
        • Contact:
        • Principal Investigator:
          • Cherie Abraham, MD
      • Portland, Oregon, United States, 97239
        • Recruiting
        • U.S. Department of Veterans Affairs, VA Portland Health Care System
        • Contact:
        • Principal Investigator:
          • Matthew Koopmann, MD
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Health Network
        • Contact:
        • Principal Investigator:
          • Benjamin Jackson, MD
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Principal Investigator:
          • Satish Muluk, MD
        • Contact:
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Wellmont Cardiology Services
        • Contact:
          • Joshua Lester
        • Principal Investigator:
          • Robert Allen, MD
    • Texas
      • Galveston, Texas, United States, 77555
        • Recruiting
        • The University of Texas Medical Branch at Galveston
        • Principal Investigator:
          • Michael Silva, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Research Institute
        • Principal Investigator:
          • Alan Lumsden, MD
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Hospitals
        • Principal Investigator:
          • Animesh Rathore, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alto Abdominal Stent Graft System
Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
Device: Alto Abdominal Stent Graft System
Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
Active Comparator: Comparators
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.
Device: FDA Approved EVAR AAA Graft Systems
FDA approved comparator of choice

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of participants All Cause Mortality
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Count of participants AAA-related Mortality
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Number of Type Ia endoleaks
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Number of Type Ib
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Number of Type II
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Number of Type III
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Number of Type IV
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Number of Unknown Enooleaks
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Number of Secondary interventions
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Count of subjects lacking device integrity
Time Frame: At 30 days, 12 months, and annually up to five years
device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak)
At 30 days, 12 months, and annually up to five years
Count of participants with conversion to open surgery
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Count of participants with type I and III endoleaks
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Count of participants with device migration (>10mm)
Time Frame: 12 months, and annually up to five years
12 months, and annually up to five years
Count of participants with aneurysm sac enlargement (>5mm)
Time Frame: 12 months, and annually up to five years
12 months, and annually up to five years
Number of Major Adverse Events (MAEs)
Time Frame: At 30 days and 12 months
All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL
At 30 days and 12 months
count of aneurysm ruptures
Time Frame: At 30 days, 12 months, and annually up to five years
At 30 days, 12 months, and annually up to five years
Count of subjects with occlusion
Time Frame: 30 days, 12 months, and annually up to five years
30 days, 12 months, and annually up to five years
Number of Participants with Freedom From device-related interventions
Time Frame: 30 days, 12 months, and annually up to five years
30 days, 12 months, and annually up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endologix

Investigators

  • Principal Investigator: Sean Lyden, MD, The Cleveland Clinic
  • Principal Investigator: Christopher Kwolek, MD, Newton-Wellesley Hospital
  • Principal Investigator: Hence Verhagen, MD, PhD, Erasmus University Study Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

September 18, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-0017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with others.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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