RECRUITING

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Quick Facts

Study Start:2021-09-20
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05064540

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult age 21 and older
  2. * Subjects with minimum of 2 year life expectancy
  3. * Subjects have signed the informed consent document
  4. * Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
  5. * Patient must be able and willing to comply with all required follow-up exams.
  1. * Currently participating in another trial where the primary endpoint has not been reached yet.
  2. * Known allergy to any of the device components
  3. * Pregnant (females of childbearing potential only)
  4. * Known connective tissue disorders
  5. * Known active infection
  6. * Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR.
  7. * 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

Study Contact

Noel DeSisto
CONTACT
864-270-8524
ndesisto@endologix.com
Sanjana Tabassum
CONTACT
stabassum@endologix.com

Principal Investigator

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

Study Locations (Sites)

Huntsville Hospital
Huntsville, Alabama, 35801
United States
University of Arizona
Tucson, Arizona, 85716
United States
Washington Regional Medical Center
Fayetteville, Arkansas, 72703
United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
United States
The Regents of the University of California, San Diego
La Jolla, California, 92093
United States
Veterans Affairs San Diego Healthcare System
San Diego, California, 92161
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20001
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Radiology and Imaging Specialists
Lakeland, Florida, 33801
United States
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
Miami, Florida, 33176
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Louisville
Louisville, Kentucky, 40202-1959
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Missouri
Columbia, Missouri, 65212
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
United States
Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)
Staten Island, New York, 10305
United States
The Cleveland Clinical Foundation
Cleveland, Ohio, 44106
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States
U.S. Department of Veterans Affairs, VA Portland Health Care System
Portland, Oregon, 97239
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
United States
Wellmont Cardiology Services
Kingsport, Tennessee, 37660
United States
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
United States
Houston Methodist Research Institute
Houston, Texas, 77030
United States
Sentara Hospitals
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Endologix

  • Sean Lyden, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
  • Christopher Kwolek, MD, PRINCIPAL_INVESTIGATOR, Newton-Wellesley Hospital
  • Hence Verhagen, MD, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-09-20
Study Completion Date2028-12

Study Record Updates

Study Start Date2021-09-20
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • randomized

Additional Relevant MeSH Terms

  • AAA
  • AAA - Abdominal Aortic Aneurysm