Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05064540
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05064540
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Endologix

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Noel DeSisto 864-270-8524 ndesisto@endologix.com
Contact: Christina Huxford Chuxford@endologix.com

Locations
Show Show 28 study locations
Sponsors and Collaborators
Endologix
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT05064540    
Other Study ID Numbers: CP-0017
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with others.

Layout table for additional information
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:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases