Not currently recruiting at UCSD

Post-Approval Study of the TREO Abdominal Stent-Graft System

a study on Abdominal Aortic Aneurysm Aneurysm

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Mahmoud B Malas, MD

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, 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
  • Cardiothoracic and Vascular Surgeons accepting new patients
    Austin Texas 78756 United States
  • Coastal Vascular and Interventional accepting new patients
    Pensacola Florida 32504 United States

Lead Scientist at UCSD

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bolton Medical
ID
NCT04697784
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated