Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Mahmoud B Malas, MD (ucsd)
Photo of Mahmoud B Malas
Mahmoud B Malas

Description

Summary

The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.

Official Title

Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

Details

This is a prospective, multi-center, non-randomized, single-arm, post-market, non-interventional study of treatment with the TREO Abdominal Stent-Graft in subjects with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms. The study will include a minimum of 300 subjects treated with the TREO Abdominal Stent-Graft at up to 55 investigational sites in the US. The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

Keywords

Abdominal Aortic Aneurysm AAA TREO EVAR Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal TREO Abdominal Stent-Graft System

Eligibility

You can join if…

Open to people ages 18 years and up

  • Willing and able to comply with all study procedures and visits.
  • Written informed consent to participate in the study.
  • Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System.
  • Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively.

You CAN'T join if...

• Medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System.

Locations

  • University of California, San Diego not yet accepting patients
    La Jolla California 92037 United States
  • VA San Diego not yet accepting patients
    San Diego California 92161 United States

Lead Scientist at University of California Health

  • Mahmoud B Malas, MD (ucsd)
    Professor of Surgery, Surgery. Authored (or co-authored) 127 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bolton Medical
ID
NCT04697784
Study Type
Interventional
Last Updated