TREO Post Approval Study

Post-Approval Study of the TREO Abdominal Stent-Graft System in Patients with Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

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Abdominal aortic aneurysm, Aortic aneurysm
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All genders
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Overview
Principal Investigator: Payam Salehi, MD, PhD

This is a prospective, multi-center, non-randomized, single arm, post-approval study. The main objective of this study is collection of the real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of abdominal aortic aneurysm (AAA) in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

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Khaled Alnahhal

Study details
Inclusion Criteria
  • The subject is willing and able to comply with all study procedures and visits.
  • The subject or their next of kin (NOK)/legally authorized representative (LAR) has given written informed consent to participate in the study.
  • In the clinical judgement of the implanting physician, the subject can be treated with the TREO Stent-Graft System.
Exclusion Criteria
  • The patient has medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving treatment with the TREO Abdominal Stent-Graft System.
Study Requirements

The study will have a 5-year follow-up period. The subjects will be asked to come for 6 follow-up visits (30 days, 1 year, 2 years, 3 years, 4 years and 5 years) following the operation. Medical information will be collected at the pre-operative visit, the operation day and all 6 follow-up visits. The follow-up visits may include any of the following tests or procedures:

  • Physical examination
  • An abdominal x-ray and x-ray type procedure called computed tomography (CT);
  • In certain instances, your physician may ask you to have a special type of CT called a gated CT (also known as a dynamic CT).
  • Observation of any health-related complications you may be having; and
  • Review of current medications.