Post-Approval Study of the TREO Abdominal Stent-Graft System (TREO PAS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: TREO Abdominal Stent-Graft System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Vascular Surgery Specialists
    • Tucson, Arizona, United States, 85718
      • Pima Heart and Vascular
  • California
    • Fresno, California, United States, 93701
      • University of California, San Francisco-Fresno
    • La Jolla, California, United States, 92037
      • University of California, San Diego
    • San Diego, California, United States, 92161
      • VA San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Gainesville, Florida, United States, 32608
      • Malcom Randall VA Medical Center
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular and Interventional
    • Tampa, Florida, United States, 33606
      • University of South Florida / Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Bay Region
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital at Washington University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10075
      • Lenox Hill Hospital / Northwell Health
    • Stony Brook, New York, United States, 11794-8191
      • Stony Brook Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Asheville, North Carolina, United States, 27607
      • Mission Health
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97239
      • VA Portland Healthcare System
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Cardiology Services
  • Texas
    • Austin, Texas, United States, 78756
      • St. David's Healthcare (Cardiothoracic and Vascular Surgeons)
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Virginia
    • Norfolk, Virginia, United States, 22042
      • Sentara Heart Hospital
    • Richmond, Virginia, United States, 23282
      • Virginia Commonwealth University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects who receive the TREO Abdominal Stent-Graft System; Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System.	Device: TREO Abdominal Stent-Graft System; The TREO Abdominal Stent-Graft System is intended for the treatment of infrarenal abdominal aortic aneurysms with or without iliac involvement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with technical success at the conclusion of the index procedure	Defined as the following: successful delivery (i.e., ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery);; successful and accurate deployment (deployment of the endovascular stent graft in the planned location; patency of the endovascular stent graft, absence of device deformations such as kinks, stent eversion, mal-deployment, misaligned deployment, requiring unplanned placement of an additional device within the endovascular stent graft, and; successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal)	Through 5 Years post-procedure
Major Adverse Events	Incidence of the following Major Adverse Events; Myocardial infarction according to SCAI definition; Stroke according to the VARC-2 guidelines; New Onset Renal Failure requiring permanent dialysis; New onset Respiratory Failure requiring permanent home oxygen therapy through 30 days; Permanent Paralysis/Paraplegia; Bowel Ischemia; Procedural blood loss (≥ 1000cc)	Through 5 Years post-procedure
Incidence of procedure-related clinical utility measures	Reporting of procedural data collected during implant of the TREO Abdominal Stent-Graft System including: Procedure time (minutes), Fluoroscopy time (minutes), Contrast volume (mL), Access method (i.e. percutaneous, surgical cut down), Length of ICU stay (hours), Length of hospital stay post-procedure (days), Anesthesia Type.	Through 5 Years post-procedure
Incidence of procedure-related complications	Incidence of adverse events occurring during or following the implant determined by the CEC to be procedure-related.	Through 5 Years post-procedure
Incidence of successful aneurysm treatment	Successful aneurysm treatment is defined as: Technical success; Absence of death from the initial procedure, secondary intervention or aortic-related cause.; Absence of persistent type I or III endoleaks; Absence of aneurysm sac expansion >5 mm; Absence of device migration >10mm; Absence of failure due to device integrity issues; Absence of aneurysm rupture; Absence of conversion to open surgical repair; Absence of permanent paraplegia, disabling stroke or dialysis that resulted from the initial operation or a secondary intervention to treat the original aortic pathology.	12 months post-implant
Incidence of all-cause mortality	Rate of mortality attributed to any causality as confirmed by the CEC.	Through 5 Years post-procedure
Incidence of aneurysm-related mortality	Rate of mortality attributed to the following causes as confirmed by the CEC: death due to a rupture, death within 30 days or prior to hospital discharge from primary procedure, or death within 30 days or prior to hospital discharge for a secondary procedure designed to treat the original aneurysm.	Through 5 Years post-procedure
Incidence of aneurysm rupture	Incidence of rupture of the native aneurysm sac post-implantation of the endograft as confirmed by the CEC.	Through 5 Years post-procedure
Incidence of secondary interventions.	Incidence of secondary procedures designed to treat or repair the original aneurysm treated with the TREO Abdominal Stent-Graft System	Through 5 Years post-procedure
Incidence of conversion to open surgical repair.	Incidence of conversion to open surgical AAA repair during the initial EVAR procedure secondary to any procedure-related complications as determined by the CEC.	Through 5 Years post-procedure
Incidence of stent-graft occlusion (i.e., loss of patency)	Incidence of stent-graft occlusion defined as the unintentional obstruction of the vascular/endograft lumen with minor obstruction (0-25%), minimal obstruction (26-74%), moderate obstruction (75-99%) or occlusion (100%) as confirmed by the Imaging Core Lab due to causes such as twisting or kinking of the prosthesis, oversizing and fabric pleating, or failure of the implant to fully open, or to mural thrombus deposition.	Through 5 Years post-procedure
Incidence of device stenosis or kink	Incidence of stenosis or kinking of the TREO Stent-Graft as confirmed by the Imaging Core Lab.	Through 5 Years post-procedure
Incidence of loss of device integrity	Incidence of changes in the structural integrity in a material component of the stent-graft such as a stent-strut fracture or separation of the proximal fixation barbs as confirmed by the Imaging Core Lab.	Through 5 Years post-procedure
Incidence of aneurysm enlargement (>5mm as compared to 30-day imaging).	Incidence of the increase in the aneurysm sac diameter > 5 mm at post-implant follow-up visits relative to the diameter determined at the first post-procedural imaging study, as confirmed by the Imaging Core Lab.	Through 5 Years post-procedure
Incidence of stent-graft migration (>10mm as compared to 30-day imaging)	Incidence of the longitudinal movement of all or part of a stent or attachment system for a distance of >10 mm relative to anatomical landmarks that were determined at the first post-procedural imaging study as confirmed by the Imaging Core Lab.	Through 5 Years post-procedure
Incidence of Type I, II, III, IV or V Endoleaks	Incidence of Type I, II, III, IV or V Endoleaks defined as the persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft as determined by the Imaging Core Lab.	Through 5 Years post-procedure

Collaborators and Investigators

• Sponsor: Bolton Medical
• Investigators: Study Director: Gretchen Wild, Terumo Aortic

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: AAA; EVAR; Abdominal Aortic Aneurysm; TREO
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: IP-0021-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes