JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Huntsville Hospital
ACTIVE_NOT_RECRUITING
Huntsville
Arkansas
Washington Regional Medical Center
RECRUITING
Fayetteville
Central Arkansas Veterans Healthcare System
RECRUITING
Little Rock
Arizona
University of Arizona
RECRUITING
Tucson
California
The Regents of the University of California, San Diego
RECRUITING
La Jolla
Veterans Affairs San Diego Healthcare System
RECRUITING
San Diego
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
Radiology and Imaging Specialists
RECRUITING
Lakeland
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
RECRUITING
Miami
Iowa
University of Iowa Hospitals and Clinics
ACTIVE_NOT_RECRUITING
Iowa City
Kentucky
University of Louisville
RECRUITING
Louisville
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Michigan
Henry Ford Hospital
WITHDRAWN
Detroit
Missouri
University of Missouri
RECRUITING
Columbia
New Jersey
Newark Beth Israel Medical Center
RECRUITING
Newark
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)
RECRUITING
Staten Island
Ohio
The Cleveland Clinical Foundation
RECRUITING
Cleveland
The Ohio State University
WITHDRAWN
Columbus
Oregon
Oregon Health Sciences University
RECRUITING
Portland
U.S. Department of Veterans Affairs, VA Portland Health Care System
RECRUITING
Portland
Pennsylvania
Lehigh Valley Health Network
RECRUITING
Allentown
University of Pennsylvania
RECRUITING
Philadelphia
Allegheny Health Network
RECRUITING
Pittsburgh
Tennessee
Wellmont Cardiology Services
RECRUITING
Kingsport
Texas
The University of Texas Medical Branch at Galveston
RECRUITING
Galveston
Houston Methodist Research Institute
RECRUITING
Houston
Virginia
Sentara Hospitals
RECRUITING
Norfolk
Contact Information
Primary
Noel DeSisto
ndesisto@endologix.com
864-270-8524
Backup
Sanjana Tabassum
stabassum@endologix.com
Time Frame
Start Date: 2021-09-20
Estimated Completion Date: 2031-03
Participants
Target number of participants: 450
Treatments
Experimental: Alto Abdominal Stent Graft System
Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
Active_comparator: Comparators
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.
Authors
Sponsors
Leads: Endologix

This content was sourced from clinicaltrials.gov