Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Mahmoud Malas, MDAndrew Barleben, MD
Headshot of Mahmoud Malas
Mahmoud Malas
Headshot of Andrew Barleben
Andrew Barleben

Description

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).

Keywords

AAA AAA - Abdominal Aortic Aneurysm randomized Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Alto Abdominal Stent Graft System FDA Approved EVAR AAA Graft Systems

Eligibility

You can join if…

Open to people ages 21 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • The Regents of the University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • Veterans Affairs San Diego Healthcare System accepting new patients
    San Diego California 92161 United States

Lead Scientists at UCSD

  • Mahmoud Malas, MD
    Professor of Surgery, Surgery, Health Sciences. Authored (or co-authored) 127 research publications
  • Andrew Barleben, MD
    Associate Professor Of Clinical, Surgery, Vc-health Sciences-schools. Authored (or co-authored) 49 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Endologix
ID
NCT05064540
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated