Principal Investigator: Claire Griffin
Keywords: TREO AAA Abdominal Stent-Graft System , Aneurysm , Phase IV , medical device , Clinical trial , Terumo Aortic , Bolton Department: Vascular Surgery Development
IRB Number: 00138928 Co Investigator: Benjamin Brooke
Specialty: Vascular Surgery, Surgery, General
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Julie  Beckstrom

Brief Summary

To collect real world safety and effectiveness outcomes of the FDA-Approved 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

Consecutive subjects diagnosed with infrarenal AAA, with or without iliac artery involvement that, in the opinion of the investigator, are suitable for treatment with the TREO Stent-Graft System. 

  1. Patient is willing and able to comply with all study procedures and visits.
  2. Patient or legally authorized representative (LAR) has given written informed consent to participate in the study. 
  3. In the clinical judgement of the implanting physician, the patient can be treated with the TREO Stent-Graft System.
  4. Patients must have adequate data available to analyze the primary endpoints for retrospectively consented patients. 

Retrospective Enrollment:

Patients treated with the TREO Abdominal Stent-Graft System that meet all inclusion and none of the exclusion criteria may be enrolled retrospectively, provided that assessments can be completed to allow for inclusion of the 30-day follow-up visit imaging and assessment of the primary endpoints. 

Exclusion Criteria

  1. 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.