Post-Approval Study of the TREO Abdominal Stent-Graft System
TREO PAS
1 other identifier
interventional
338
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
June 26, 2025
June 1, 2025
6.5 years
December 10, 2020
June 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.
Incidence of fracture in a stent-strut or separation of one or more proximal fixation barbs as confirmed by the Imaging Core Laboratory upon review of post-implant imaging studies.
Through 5 Years post-procedure
Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation.
Incidence of secondary intervention for adverse events related to or caused as a result of a fracture in a stent-strut or separation of one or more proximal fixation barbs. Relatedness to the device will be confirmed by the Clinical Events Committee (CEC) through review of available treatment and procedure records and reports of imaging studies.
Through 5 Years post-procedure
Secondary Outcomes (16)
Number of participants with technical success at the conclusion of the index procedure
Through 5 Years post-procedure
Major Adverse Events
Through 5 Years post-procedure
Incidence of procedure-related clinical utility measures
Through 5 Years post-procedure
Incidence of procedure-related complications
Through 5 Years post-procedure
Incidence of successful aneurysm treatment
12 months post-implant
- +11 more secondary outcomes
Study Arms (1)
Subjects who receive the TREO Abdominal Stent-Graft System
EXPERIMENTALEligible subjects will be implanted with the TREO Abdominal Stent-Graft System.
Interventions
The TREO Abdominal Stent-Graft System is intended for the treatment of infrarenal abdominal aortic aneurysms with or without iliac involvement.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bolton Medicallead
Study Sites (40)
Vascular Surgery Specialists
Phoenix, Arizona, 85006, United States
Pima Heart and Vascular
Tucson, Arizona, 85718, United States
University of California, San Francisco-Fresno
Fresno, California, 93701, United States
University of California, San Diego
La Jolla, California, 92037, United States
VA San Diego
San Diego, California, 92161, United States
University of Colorado Anschutz
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06520, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Malcom Randall VA Medical Center
Gainesville, Florida, 32608, United States
University of Florida
Gainesville, Florida, 32610, United States
Coastal Vascular and Interventional
Pensacola, Florida, 32504, United States
University of South Florida / Tampa General Hospital
Tampa, Florida, 33606, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
University of Iowa Hospital and Clinic
Iowa City, Iowa, 52242, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
McLaren Bay Region
Bay City, Michigan, 48708, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Barnes Jewish Hospital at Washington University
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Rutgers Robert Wood Johnson Medical Center
New Brunswick, New Jersey, 08901, United States
Lenox Hill Hospital / Northwell Health
New York, New York, 10075, United States
Stony Brook Medical Center
Stony Brook, New York, 11794-8191, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Mission Health
Asheville, North Carolina, 27607, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
VA Portland Healthcare System
Portland, Oregon, 97239, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Wellmont Cardiology Services
Kingsport, Tennessee, 37660, United States
St. David's Healthcare (Cardiothoracic and Vascular Surgeons)
Austin, Texas, 78756, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Sentara Heart Hospital
Norfolk, Virginia, 22042, United States
Virginia Commonwealth University
Richmond, Virginia, 23282, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gretchen Wild
Terumo Aortic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2020
First Posted
January 6, 2021
Study Start
January 20, 2021
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
June 26, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share