An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

Status Terminated

Clinical Trial Summary

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644. The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.

Clinical Trial Description

This is a prospective, multicenter, post-market clinical follow-up, non-randomized registry of the TREO Stent-Graft. Subjects diagnosed with infrarenal aortic aneurysms and treated with the TREO Stent-Graft or TREO aorto-uni-iliac (AUI) device can be included into the registry. Pre-procedure baseline data will be gathered as well as post-procedure assessments prior to hospital discharge and one to three months and 1, 2, 3, 4, and 5-year post-implantation. The objective of the registry is to assess the clinical results and health economics of the TREO device in a real-world population of patients with infrarenal abdominal aortic aneurysms (AAA). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03187522
Study type	Interventional
Source	Bolton Medical
Contact
Status	Terminated
Phase	N/A
Start date	June 22, 2017
Completion date	December 30, 2020

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