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

• ClinicalTrials.gov Identifier: NCT04697784
• Recruitment Status: Recruiting
• First Posted: January 6, 2021
• Last Update Posted: May 16, 2022
• Sponsor: Bolton Medical
• Information provided by (Responsible Party): Bolton Medical

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Abdominal Aortic Aneurysm	Device: TREO Abdominal Stent-Graft System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Abdominal Aortic Aneurysm Stent-Graft
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms
• Actual Study Start Date: January 20, 2021
• Estimated Primary Completion Date: July 31, 2027
• Estimated Study Completion Date: July 31, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory. [ Time Frame: Through 5 Years post-procedure ]
   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.
2. Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation. [ Time Frame: Through 5 Years post-procedure ]
   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.

Secondary Outcome Measures :

1. Number of participants with technical success at the conclusion of the index procedure [ Time Frame: Through 5 Years post-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)
2. Major Adverse Events [ Time Frame: Through 5 Years post-procedure ]

   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)
3. Incidence of procedure-related clinical utility measures [ Time Frame: Through 5 Years post-procedure ]
   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.
4. Incidence of procedure-related complications [ Time Frame: Through 5 Years post-procedure ]
   Incidence of adverse events occurring during or following the implant determined by the CEC to be procedure-related.
5. Incidence of successful aneurysm treatment [ Time Frame: 12 months post-implant ]

   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.
6. Incidence of all-cause mortality [ Time Frame: Through 5 Years post-procedure ]
   Rate of mortality attributed to any causality as confirmed by the CEC.
7. Incidence of aneurysm-related mortality [ Time Frame: Through 5 Years post-procedure ]
   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.
8. Incidence of aneurysm rupture [ Time Frame: Through 5 Years post-procedure ]
   Incidence of rupture of the native aneurysm sac post-implantation of the endograft as confirmed by the CEC.
9. Incidence of secondary interventions. [ Time Frame: Through 5 Years post-procedure ]
   Incidence of secondary procedures designed to treat or repair the original aneurysm treated with the TREO Abdominal Stent-Graft System
10. Incidence of conversion to open surgical repair. [ Time Frame: Through 5 Years post-procedure ]
    Incidence of conversion to open surgical AAA repair during the initial EVAR procedure secondary to any procedure-related complications as determined by the CEC.
11. Incidence of stent-graft occlusion (i.e., loss of patency) [ Time Frame: Through 5 Years post-procedure ]
    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.
12. Incidence of device stenosis or kink [ Time Frame: Through 5 Years post-procedure ]
    Incidence of stenosis or kinking of the TREO Stent-Graft as confirmed by the Imaging Core Lab.
13. Incidence of loss of device integrity [ Time Frame: Through 5 Years post-procedure ]
    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.
14. Incidence of aneurysm enlargement (>5mm as compared to 30-day imaging). [ Time Frame: Through 5 Years post-procedure ]
    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.
15. Incidence of stent-graft migration (>10mm as compared to 30-day imaging) [ Time Frame: Through 5 Years post-procedure ]
    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.
16. Incidence of Type I, II, III, IV or V Endoleaks [ Time Frame: Through 5 Years post-procedure ]
    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.

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Gretchen Wild; 954-779-6393; g.wild@terumoaortic.com

Locations

United States, Arizona

Banner University Medical Center; Not yet recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator: Jeromy Brink, MD

Pima Heart and Vascular; Not yet recruiting

Tucson, Arizona, United States, 85718

Principal Investigator: Scott Berman, MD

United States, California

University of California, San Diego; Not yet recruiting

La Jolla, California, United States, 92037

Principal Investigator: Mahmoud B Malas, MD

Long Beach Memorial Hospital; Not yet recruiting

Long Beach, California, United States, 90806

Principal Investigator: Ankur Gupta, MD

VA San Diego; Not yet recruiting

San Diego, California, United States, 92161

Principal Investigator: Andrew Barleben, MD

United States, Colorado

University of Colorado Anschutz; Not yet recruiting

Aurora, Colorado, United States, 80045

Principal Investigator: Donald Jacobs, MD

United States, Connecticut

Yale University; Not yet recruiting

New Haven, Connecticut, United States, 06520

Principal Investigator: Naiem Nassiri, MD

United States, District of Columbia

Medstar Washington Hospital Center; Not yet recruiting

Washington, District of Columbia, United States, 20010

Principal Investigator: Javairiah Fatima, MD

United States, Florida

Boca Raton Regional Hospital; Not yet recruiting

Boca Raton, Florida, United States, 33486

Principal Investigator: W. Anthony Lee, MD

University of Florida; Not yet recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: Martin Back, MD

Mount Sinai Medical Center; Not yet recruiting

Miami, Florida, United States, 33181

Principal Investigator: Micheal Ayad, MD

Coastal Vascular and Interventional; Recruiting

Pensacola, Florida, United States, 32504

Principal Investigator: Christopher LeCroy, MD

University of South Florida / Tampa General Hospital; Not yet recruiting

Tampa, Florida, United States, 33606

Principal Investigator: Murray Shames, MD

United States, Georgia

Piedmont Heart Institute; Not yet recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator: Andrew Unzeitig, MD

United States, Iowa

University of Iowa Hospital and Clinic; Not yet recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator: Melhem Sharafuddin, MD

United States, Massachusetts

Tufts Medical Center; Not yet recruiting

Boston, Massachusetts, United States, 02111

Principal Investigator: Payam Salehi, MD, PhD

United States, Michigan

McLaren Bay Region; Recruiting

Bay City, Michigan, United States, 48708

Principal Investigator: Nicolas Mouawad, MD

Henry Ford Hospital; Not yet recruiting

Detroit, Michigan, United States, 48202

Principal Investigator: Loay Kabbani, MD

United States, Minnesota

Minneapolis Heart Institute / Abbott Northwestern Hospital; Not yet recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator: Jessica Titus, MD

United States, Missouri

Barnes Jewish Hospital at Washington University; Not yet recruiting

Saint Louis, Missouri, United States, 63110

Principal Investigator: Luis Sanchez, MD

United States, New Jersey

Rutgers Robert Wood Johnson Medical Center; Not yet recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator: Saum Rahimi, MD

United States, New York

Montefiore Medical Center; Not yet recruiting

Bronx, New York, United States, 10467

Principal Investigator: Evan Lipsitz, MD

Sisters of Charity Hospital, Catholic Health System; Not yet recruiting

Buffalo, New York, United States, 14221

Principal Investigator: Paul Anain, MD

The Mount Sinai Hospital; Not yet recruiting

New York, New York, United States, 10029

Principal Investigator: James McKinsey, MD

Lenox Hill Hospital / Northwell Health; Not yet recruiting

New York, New York, United States, 10075

Principal Investigator: Alfio Carroccio, MD

University of Rochester -- Strong Memorial Hospital; Not yet recruiting

Rochester, New York, United States, 14623

Principal Investigator: Michael Stoner, MD

Stony Brook Medical Center; Not yet recruiting

Stony Brook, New York, United States, 11794-8191

Principal Investigator: Apostolos Tassiopoulos, MD

United States, North Carolina

Mission Health; Not yet recruiting

Asheville, North Carolina, United States, 27607

Principal Investigator: John Henretta, MD

East Carolina University; Not yet recruiting

Greenville, North Carolina, United States, 27834

Principal Investigator: Frank Parker, MD

UNC Rex Hospital; Not yet recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator: Robert Mendes, MD

United States, Oklahoma

Oklahoma University Health and VA Medical Center; Not yet recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator: Joshua Gierman, MD

United States, Oregon

Oregon Health and Sciences University; Not yet recruiting

Portland, Oregon, United States, 97239

Principal Investigator: Amani Politano, MD

United States, Pennsylvania

University of Pittsburg Medical Center; Not yet recruiting

Pittsburgh, Pennsylvania, United States, 15232

Principal Investigator: Michael Singh, MD

United States, South Dakota

Sanford University of South Dakota Medical Center; Not yet recruiting

Sioux Falls, South Dakota, United States, 57117

Principal Investigator: Angelo Santos, MD

United States, Texas

Cardiothoracic and Vascular Surgeons; Recruiting

Austin, Texas, United States, 78756

Principal Investigator: Mazin Foteh, MD

Methodist Hospital; Not yet recruiting

Houston, Texas, United States, 77030

Principal Investigator: Charlie Cheng, MD

United States, Utah

University of Utah Hospital; Not yet recruiting

Salt Lake City, Utah, United States, 84132

Principal Investigator: Claire Griffin, MD

United States, Virginia

Sentara Heart Hospital; Not yet recruiting

Norfolk, Virginia, United States, 22042

Principal Investigator: Jean Panneton, MD

Virginia Commonwealth University; Not yet recruiting

Richmond, Virginia, United States, 23282

Principal Investigator: Daniel Newton, MD

United States, Wisconsin

Medical College of Wisconsin; Not yet recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator: Peter Rossi, MD

Sponsors and Collaborators

Bolton Medical

More Information

• Responsible Party: Bolton Medical
• ClinicalTrials.gov Identifier: NCT04697784
• Other Study ID Numbers: IP-0021-20
• First Posted: January 6, 2021
• Last Update Posted: May 16, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Bolton Medical:

AAA; Abdominal Aortic Aneurysm; TREO; EVAR

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases