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AAAJAGUARNCT05064540

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

A study testing Alto Abdominal Stent Graft System and FDA Approved EVAR AAA Graft Systems in people with AAA and AAA - Abdominal Aortic Aneurysm, run by Endologix at 29 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
AAA, AAA - Abdominal Aortic Aneurysm
What is being tested?
Alto Abdominal Stent Graft System and FDA Approved EVAR AAA Graft Systems
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
29 sitesUnited States
Study dates
20 Sep 2021to Mar 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Noel DeSisto contact

864-270-8524

ndesisto@endologix.com

Sanjana Tabassum contact

stabassum@endologix.com

29 sites in 1 country

United States29 sites, 25 recruiting

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

    Deborah Mankos, 610-402-1635, deborah.mankos@lvhn.org

    Benjamin Jackson, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

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

    Shivani Kumar, MD

    Recruiting

  • The Cleveland Clinical Foundation

    Cleveland, Ohio, 44106

    Larissa Schaaf, RN, (216) 445-4437, schaafl@ccf.org

    Francis Caputo, Dr.

    Recruiting

  • University of Missouri

    Columbia, Missouri, 65212

    Jennifer Randolph, 573-882-4387, Randolphjl@health.missouri.edu

    Todd Vogel, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Withdrawn

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Withdrawn

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

    Callie McQueen, 479-463-7858, cmcqueen@wregional.com

    Russell Wood

    Recruiting

  • The University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

    Sana Malik, 409-747-7333, sanmalik@utmb.edu

    Michael Silva, MD

    Recruiting

  • Houston Methodist Research Institute

    Houston, Texas, 77030

    Solange Basagoitia, 713-441-0176, smbasagoitia@houstonmethodist.org

    Alan Lumsden, MD

    Recruiting

  • Huntsville Hospital

    Huntsville, Alabama, 35801

    Active, not recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Active, not recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

    Lisa Joseph, 904.732.2217, ljoseph@encoredocs.com

    Erin Moore, MD

    Recruiting

  • Wellmont Cardiology Services

    Kingsport, Tennessee, 37660

    Joshua Lester

    Robert Allen, MD

    Recruiting

  • The Regents of the University of California, San Diego

    La Jolla, California, 92093

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

    Mahmoud Malas, MD

    Recruiting

  • Radiology and Imaging Specialists

    Lakeland, Florida, 33801

    Eve Johnson, 863-688-2334 ext. 135, ejohnson@risimaging.com

    Fakhir Elmasri, MD

    Recruiting

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205

    Sandra Brock, 501-257-6906, sandra.brock@va.gov

    Lauren Story-Hefta

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202-1959

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

    Amit Dwivedi, MD

    Recruiting

  • Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

    Miami, Florida, 33176

    David Fernandez, 786-596-5392, davidfer@baptisthealth.net

    Mikaela Bearham, 786-596-4079, MikaelaB@baptisthealth.net

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029-6574

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

    Sung Yup Kim, MD

    Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Debra Cook, Debra.cook@rwjbh.org

    Bruce Brener, MD

    Recruiting

  • Sentara Hospitals

    Norfolk, Virginia, 23507

    Kara Wiggins, MSN, RN, 757-388-7511, KVWIGGIN@sentara.com

    Animesh Rathore, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Thomas Hebert, 973-454-3066, thomas.hebert@pennmedicine.upenn.edu

    Venkat Kalapatapu, MD

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

    Sheila Bernardini, sheila.bernardini@ahn.org

    Satish Muluk, MD

    Recruiting

  • Oregon Health Sciences University

    Portland, Oregon, 97239

    Amie Lorisch, lorischa@ohsu.edu

    Cherie Abraham, MD

    Recruiting

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

    Portland, Oregon, 97239

    Jin Kim, jin.kim9@va.gov

    Rachel Nelson, 503-220-8262 ext. 58388, rachel.nelson1@va.gov

    Recruiting

  • Veterans Affairs San Diego Healthcare System

    San Diego, California, 92161

    Annalicia Vargas, annalicia.vargas@va.gov

    Ann Gaffey, MD

    Recruiting

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

    Staten Island, New York, 10305

    Alexandra Pantea, 718-226-6438, apantea@northwell.edu

    Shannen Belotte, 718-226-8559, sbelotte@northwell.edu

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85716

    Karen Sanchez, kas10@arizona.edu

    Wei Zhou, MD

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20001

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

    Kyle Reynolds, MD

    Recruiting

Other trials in United States

About this study

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).

Being tested
Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems
Keywords
randomized
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alto Abdominal Stent Graft SystemDevice

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

  • FDA Approved EVAR AAA Graft SystemsDevice

    FDA approved comparator of choice

Study groups in NCT05064540
Study groupRoleWhat they receive
Alto Abdominal Stent Graft SystemExperimentalSubjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
Receives: Device: Alto Abdominal Stent Graft System
ComparatorsActive comparatorSubjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.
Receives: Device: FDA Approved EVAR AAA Graft Systems

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through 5 years

  2. Neck Dilation in mm

    Measured: Through 5 years

Secondary outcomes (18)

  1. Number of Major Adverse Events (MAEs)

    All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL

    Measured: At 30 days and 12 months

  2. Count of participants All Cause Mortality

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

  3. Count of participants AAA-related Mortality

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

  4. Number of Type Ia endoleaks

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

  5. Number of Type Ib

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

  6. Number of Type II

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

  7. Number of Type III

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

  8. Number of Type IV

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

  9. Number of Unknown Enooleaks

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

  10. Number of Secondary interventions

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

  11. Count of subjects lacking device integrity

    device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak)

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

  12. count of aneurysm ruptures

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

  13. Count of participants with conversion to open surgery

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

  14. Count of participants with type I and III endoleaks

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

  15. Count of participants with device migration (>10mm)

    Measured: 12 months, and annually up to five years

  16. Count of participants with aneurysm sac enlargement (>5mm)

    Measured: 12 months, and annually up to five years

  17. Count of subjects with occlusion

    Measured: 30 days, 12 months, and annually up to five years

  18. Number of Participants with Freedom From device-related interventions

    Measured: 30 days, 12 months, and annually up to five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start20 Sep 2021
  3. Primary completionMar 2032 (estimated)
  4. Study completionMar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05064540
Sponsor's protocol ID
CP-0017
Acronym
JAGUAR
Status last verified
Sep 2026
First submitted
18 Sep 2021
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared with others.

Questions about this trial

What is this clinical trial studying?

A study testing Alto Abdominal Stent Graft System and FDA Approved EVAR AAA Graft Systems in people with AAA and AAA - Abdominal Aortic Aneurysm, run by Endologix at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Noel DeSisto (864-270-8524, ndesisto@endologix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Freedom from Aneurysm-Related Complications (ARC) (time frame: Through 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05064540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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