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.

Edad: 18 años o más

Género: Todos

Fecha de inicio: 01/20/2021

Fecha de finalización principal (estimada): 07/31/2027

Fecha estimada de finalización del estudio: 07/31/2027

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

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.

Criterios de elegibilidad

Edad: 18 años o más

Género: Todos

Acepta voluntarios sanos: No

Criterios de inclusión:

* 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.

Criterios de exclusión:

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