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

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ClinicalTrials.gov Identifier: NCT05064540
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Endologix

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).


Condition or disease Intervention/treatment Phase
AAA AAA - Abdominal Aortic Aneurysm Device: Alto Abdominal Stent Graft System Device: FDA Approved EVAR AAA Graft Systems Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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




Primary Outcome Measures :
  1. 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

  2. Neck Dilation in mm [ Time Frame: Through 5 years ]

Secondary Outcome Measures :
  1. 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

  2. Count of participants All Cause Mortality [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  3. Count of participants AAA-related Mortality [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  4. Number of Type Ia endoleaks [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  5. Number of Type Ib [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  6. Number of Type II [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  7. Number of Type III [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  8. Number of Type IV [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  9. Number of Unknown Enooleaks [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  10. Number of Secondary interventions [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  11. 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)

  12. count of aneurysm ruptures [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  13. Count of participants with conversion to open surgery [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  14. Count of participants with type I and III endoleaks [ Time Frame: At 30 days, 12 months, and annually up to five years ]
  15. Count of participants with device migration (>10mm) [ Time Frame: 12 months, and annually up to five years ]
  16. Count of participants with aneurysm sac enlargement (>5mm) [ Time Frame: 12 months, and annually up to five years ]
  17. Count of subjects with occlusion [ Time Frame: 30 days, 12 months, and annually up to five years ]
  18. Number of Participants with Freedom From device-related interventions [ Time Frame: 30 days, 12 months, and annually up to five years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05064540


Contacts
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Contact: Noel DeSisto 864-270-8524 ndesisto@endologix.com
Contact: Christina Huxford Chuxford@endologix.com

Locations
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United States, Arkansas
Washington Regional Medical Center Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Callie McQueen    479-463-7858    cmcqueen@wregional.com   
Principal Investigator: Russell Wood         
United States, California
The Regents of the University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: 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
Contact: Annalicia Romero       annalicia.romero@va.gov   
Principal Investigator: Andrew Barleben, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20001
Contact: Kassaye Sesaba    202-877-7452    Kassaye.T.Sesaba@medstar.net   
Principal Investigator: Fatima Javariah, MD         
United States, Florida
Radiology and Imaging Specialists Recruiting
Lakeland, Florida, United States, 33801
Contact: Eve Johnson    863-688-2334 ext 135    ejohnson@risimaging.com   
Principal Investigator: Tushar Barot, MD         
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute Recruiting
Miami, Florida, United States, 33176
Contact: Mariana Perez de Alderete, RN    786-596-2058    marianapere@baptisthealth.net   
Contact: Mikaela Bearham    786-596-4079    MikaelaB@baptisthealth.net   
Principal Investigator: Constantino Pena, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Judith Pena-Quevedo, RN, MSN    319-353-8736      
Principal Investigator: Mel Sharafuddin, MD         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Jennifer Randolph    573-882-4387    Randolphjl@health.missouri.edu   
Principal Investigator: Todd Vogel, MD         
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Debra Cook       Debra.cook@rwjbh.org   
Principal Investigator: Bruce Brener, MD         
United States, New York
Feinstein Institutes for Medical Research (Northwell) Recruiting
Staten Island, New York, United States, 10305
Contact: Alexandra Pantea    718-226-6438    apantea@northwell.edu   
Principal Investigator: Kuldeep Singh, MD         
United States, Ohio
The Cleveland Clinical Foundation Recruiting
Cleveland, Ohio, United States, 44106
Contact: Carmen Czich, RN    216-315-1568    CZICHC@ccf.org   
Principal Investigator: Jarrad Rowse, Dr.         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Courteney Ly    856-381-9687    courteney.ly@pennmedicine.upenn.edu   
Principal Investigator: Venkat Kalapatapu, MD         
United States, Tennessee
Wellmont Cardiology Services Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Joshua Lester         
Principal Investigator: Christopher Metzger, MD         
United States, Texas
The University of Texas Medical Branch at Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Rachel Minesinger    409-747-7333    RAMINESI@UTMB.EDU   
Principal Investigator: Michael Silva, MD         
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Ruth Medcalf    346-238-1131    rmedcalf@houstonmethodist.org   
Principal Investigator: Alan Lumsden, MD         
United States, Virginia
Sentara Hospitals Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant, MSN, RN    757-388-4024    mmbulliv@sentara.com   
Principal Investigator: Jean M. Panneton, MD         
Sponsors and Collaborators
Endologix
Investigators
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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
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Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT05064540    
Other Study ID Numbers: CP-0017
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with others.

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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
Keywords provided by Endologix:
randomized
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases