Post-Approval Study of the TREO Abdominal Stent-Graft System
Post-Approval Study of the TREO Abdominal Stent-Graft System
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.
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

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