Overview
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.
Principal investigator
Eligibility 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.
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