Post-Approval Study of the TREO Abdominal Stent-Graft System

Running, not enrolling · Not applicable

Conditions studied: Abdominal Aortic Aneurysm

In brief

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.

Key facts

Study ID

NCT04697784

Run by

Bolton Medical

People needed

338

Starts

2021-01-20

Expected to finish

2027-07-31

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Vascular Surgery Specialists — Phoenix, Arizona, United States
• Pima Heart and Vascular — Tucson, Arizona, United States
• University of California, San Francisco-Fresno — Fresno, California, United States
• University of California, San Diego — La Jolla, California, United States
• VA San Diego — San Diego, California, United States
• University of Colorado Anschutz — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Malcom Randall VA Medical Center — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Coastal Vascular and Interventional — Pensacola, Florida, United States
• University of South Florida / Tampa General Hospital — Tampa, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• University of Iowa Hospital and Clinic — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• McLaren Bay Region — Bay City, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Barnes Jewish Hospital at Washington University — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Rutgers Robert Wood Johnson Medical Center — New Brunswick, New Jersey, United States
• Lenox Hill Hospital / Northwell Health — New York, New York, United States
• Stony Brook Medical Center — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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