This study is in progress, not accepting new patients

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

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
    La Jolla California 92037 United States
  • VA San Diego
    San Diego California 92161 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bolton Medical
ID
NCT04697784
Study Type
Interventional
Participants
About 338 people participating
Last Updated