JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

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).

Conditions

AAA, AAA - Abdominal Aortic Aneurysm

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Study Overview

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Study Details

Study overview

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).

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Condition
AAA
Intervention / Treatment

-

Contacts and Locations

Huntsville

Huntsville Hospital, Huntsville, Alabama, United States, 35801

Tucson

University of Arizona, Tucson, Arizona, United States, 85716

Fayetteville

Washington Regional Medical Center, Fayetteville, Arkansas, United States, 72703

Little Rock

Central Arkansas Veterans Healthcare System, Little Rock, Arkansas, United States, 72205

La Jolla

The Regents of the University of California, San Diego, La Jolla, California, United States, 92093

San Diego

Veterans Affairs San Diego Healthcare System, San Diego, California, United States, 92161

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20001

Jacksonville

Jacksonville Center for Clinical Research, Jacksonville, Florida, United States, 32216

Lakeland

Radiology and Imaging Specialists, Lakeland, Florida, United States, 33801

Miami

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute, Miami, Florida, United States, 33176

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2028-12