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Long-term performance evaluation of the TREO Abdominal Stent-Graft for aneurysms

Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

Not applicable Interventional Bolton Medical · NCT04697784

This study is testing how safe and effective the TREO Abdominal Stent-Graft is for treating patients with certain types of abdominal aneurysms over the long term.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorBolton Medical Industry-sponsored
Locations40 sites (Phoenix, Arizona and 39 other locations)
Trial IDNCT04697784 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety and effectiveness of the TREO Abdominal Stent-Graft System in treating patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms. It is a prospective, multi-center, non-randomized, single-arm study involving at least 300 subjects across up to 55 sites in the US. The focus is on collecting real-world outcomes, particularly regarding device-related complications such as stent-strut or barb fractures.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms who can be treated with the TREO Abdominal Stent-Graft System.

Not a fit: Patients with medical, social, or psychological issues that prevent them from receiving treatment with the TREO Abdominal Stent-Graft System may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the TREO Abdominal Stent-Graft, potentially improving treatment options for patients with abdominal aortic aneurysms.

How similar studies have performed: Other studies have shown success with similar endovascular approaches for treating abdominal aortic aneurysms, indicating a promising avenue for this treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Abdominal Aortic AneurysmAAATREOEVAR
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.