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

Abdominal Aortic Aneurysm Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04697784
Study type Interventional
Source Bolton Medical
Contact Gretchen Wild
Phone 954-779-6393
Email g.wild@terumoaortic.com
Status Recruiting
Phase N/A
Start date January 20, 2021
Completion date July 31, 2027
View Details
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