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

Last updated: June 23, 2025
Sponsor: Bolton Medical
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Disease

Aneurysm

Cardiovascular Disease

Treatment

TREO Abdominal Stent-Graft System

Clinical Study ID

NCT04697784
IP-0021-20
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 primaryendpoints for patients enrolled retrospectively.

Exclusion

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 Design

Total Participants: 338
Treatment Group(s): 1
Primary Treatment: TREO Abdominal Stent-Graft System
Phase:
Study Start date:
January 20, 2021
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Banner University Medical Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Vascular Surgery Specialists

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Pima Heart and Vascular

    Tucson, Arizona 85718
    United States

    Site Not Available

  • University of California, San Francisco-Fresno

    Fresno, California 93701
    United States

    Site Not Available

  • University of California, San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • Long Beach Memorial Hospital

    Long Beach, California 90806
    United States

    Site Not Available

  • VA San Diego

    San Diego, California 92161
    United States

    Site Not Available

  • University of Colorado Anschutz

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Boca Raton Regional Hospital

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Malcom Randall VA Medical Center

    Gainesville, Florida 32608
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Mount Sinai Medical Center

    Miami, Florida 33181
    United States

    Site Not Available

  • Coastal Vascular and Interventional

    Pensacola, Florida 32504
    United States

    Site Not Available

  • University of South Florida / Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Northside Hospital

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • University of Iowa Hospital and Clinic

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • McLaren Bay Region

    Bay City, Michigan 48708
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Minneapolis Heart Institute / Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Barnes Jewish Hospital at Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Barnes Jewish Hospital at Washington University

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Rutgers Robert Wood Johnson Medical Center

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Sisters of Charity Hospital, Catholic Health System

    Buffalo, New York 14221
    United States

    Site Not Available

  • Lenox Hill Hospital / Northwell Health

    New York, New York 10075
    United States

    Site Not Available

  • The Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester -- Strong Memorial Hospital

    Rochester, New York 14623
    United States

    Site Not Available

  • Stony Brook Medical Center

    Stony Brook, New York 11794-8191
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Mission Health

    Asheville, North Carolina 27607
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • UNC Rex Hospital

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Oklahoma University Health and VA Medical Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • VA Portland Healthcare System

    Portland, Oregon 97239
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Sanford University of South Dakota Medical Center

    Sioux Falls, South Dakota 57117
    United States

    Site Not Available

  • Wellmont Cardiology Services

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas 78756
    United States

    Active - Recruiting

  • St. David's Healthcare (Cardiothoracic and Vascular Surgeons)

    Austin, Texas 78756
    United States

    Site Not Available

  • Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Sentara Heart Hospital

    Norfolk, Virginia 22042
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23282
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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