Back to results

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

Primary Purpose

Abdominal Aortic Aneurysm

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TREO Abdominal Stent-Graft System

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring AAA, Abdominal Aortic Aneurysm, TREO, EVAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects who receive the TREO Abdominal Stent-Graft System

Arm Description

Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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)

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)

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.

Incidence of procedure-related complications

Incidence of adverse events occurring during or following the implant determined by the CEC to be procedure-related.

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.

Incidence of all-cause mortality

Rate of mortality attributed to any causality as confirmed by the CEC.

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.

Incidence of aneurysm rupture

Incidence of rupture of the native aneurysm sac post-implantation of the endograft as confirmed by the CEC.

Incidence of secondary interventions.

Incidence of secondary procedures designed to treat or repair the original aneurysm treated with the TREO Abdominal Stent-Graft System

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.

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.

Incidence of device stenosis or kink

Incidence of stenosis or kinking of the TREO Stent-Graft as confirmed by the Imaging Core Lab.

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.

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.

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.

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.

Full Information

NCT ID

NCT04697784

First Posted

December 10, 2020

Last Updated

September 27, 2023

Sponsor

Bolton Medical

1. Study Identification

Unique Protocol Identification Number

NCT04697784

Brief Title

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

Acronym

TREO PAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2021 (Actual)

Primary Completion Date

July 31, 2027 (Anticipated)

Study Completion Date

July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bolton Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysm

Keywords

AAA, Abdominal Aortic Aneurysm, TREO, EVAR

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Abdominal Aortic Aneurysm Stent-Graft

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subjects who receive the TREO Abdominal Stent-Graft System

Arm Type

Experimental

Arm Description

Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System.

Intervention Type

Device

Intervention Name(s)

TREO Abdominal Stent-Graft System

Intervention Description

The TREO Abdominal Stent-Graft System is intended for the treatment of infrarenal abdominal aortic aneurysms with or without iliac involvement.

Primary Outcome Measure Information:

Title

Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.

Description

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.

Time Frame

Through 5 Years post-procedure

Title

Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation.

Description

Time Frame

Through 5 Years post-procedure

Secondary Outcome Measure Information:

Title

Number of participants with technical success at the conclusion of the index procedure

Description

Time Frame

Through 5 Years post-procedure

Title

Major Adverse Events

Description

Time Frame

Through 5 Years post-procedure

Title

Incidence of procedure-related clinical utility measures

Description

Time Frame

Through 5 Years post-procedure

Title

Incidence of procedure-related complications

Description

Incidence of adverse events occurring during or following the implant determined by the CEC to be procedure-related.

Time Frame

Through 5 Years post-procedure

Title

Incidence of successful aneurysm treatment

Description

Time Frame

12 months post-implant

Title

Incidence of all-cause mortality

Description

Rate of mortality attributed to any causality as confirmed by the CEC.

Time Frame

Through 5 Years post-procedure

Title

Incidence of aneurysm-related mortality

Description

Time Frame

Through 5 Years post-procedure

Title

Incidence of aneurysm rupture

Description

Incidence of rupture of the native aneurysm sac post-implantation of the endograft as confirmed by the CEC.

Time Frame

Through 5 Years post-procedure

Title

Incidence of secondary interventions.

Description

Incidence of secondary procedures designed to treat or repair the original aneurysm treated with the TREO Abdominal Stent-Graft System

Time Frame

Through 5 Years post-procedure

Title

Incidence of conversion to open surgical repair.

Description

Incidence of conversion to open surgical AAA repair during the initial EVAR procedure secondary to any procedure-related complications as determined by the CEC.

Time Frame

Through 5 Years post-procedure

Title

Incidence of stent-graft occlusion (i.e., loss of patency)

Description

Time Frame

Through 5 Years post-procedure

Title

Incidence of device stenosis or kink

Description

Incidence of stenosis or kinking of the TREO Stent-Graft as confirmed by the Imaging Core Lab.

Time Frame

Through 5 Years post-procedure

Title

Incidence of loss of device integrity

Description

Time Frame

Through 5 Years post-procedure

Title

Incidence of aneurysm enlargement (>5mm as compared to 30-day imaging).

Description

Time Frame

Through 5 Years post-procedure

Title

Incidence of stent-graft migration (>10mm as compared to 30-day imaging)

Description

Time Frame

Through 5 Years post-procedure

Title

Incidence of Type I, II, III, IV or V Endoleaks

Description

Time Frame

Through 5 Years post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gretchen Wild

Phone

954-779-6393

g.wild@terumoaortic.com

Facility Information:

Facility Name

Banner University Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeromy Brink, MD

Facility Name

Pima Heart and Vascular

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85718

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Scott Berman, MD

Facility Name

University of California, San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahmoud B Malas, MD

Facility Name

Long Beach Memorial Hospital

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ankur Gupta, MD

Facility Name

VA San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Barleben, MD

Facility Name

University of Colorado Anschutz

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Donald Jacobs, MD

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Naiem Nassiri, MD

Facility Name

Medstar Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Javairiah Fatima, MD

Facility Name

Boca Raton Regional Hospital

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

W. Anthony Lee, MD

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Back, MD

Facility Name

Mount Sinai Medical Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33181

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Micheal Ayad, MD

Facility Name

Coastal Vascular and Interventional

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher LeCroy, MD

Facility Name

University of South Florida / Tampa General Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Murray Shames, MD

Facility Name

Piedmont Heart Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Unzeitig, MD

Facility Name

University of Iowa Hospital and Clinic

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melhem Sharafuddin, MD

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Payam Salehi, MD, PhD

Facility Name

McLaren Bay Region

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48708

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Mouawad, MD

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Loay Kabbani, MD

Facility Name

Minneapolis Heart Institute / Abbott Northwestern Hospital

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Titus, MD

Facility Name

Barnes Jewish Hospital at Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Sanchez, MD

Facility Name

Rutgers Robert Wood Johnson Medical Center

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Saum Rahimi, MD

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evan Lipsitz, MD

Facility Name

Sisters of Charity Hospital, Catholic Health System

City

Buffalo

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Anain, MD

Facility Name

The Mount Sinai Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James McKinsey, MD

Facility Name

Lenox Hill Hospital / Northwell Health

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alfio Carroccio, MD

Facility Name

University of Rochester -- Strong Memorial Hospital

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Stoner, MD

Facility Name

Stony Brook Medical Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794-8191

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Apostolos Tassiopoulos, MD

Facility Name

Mission Health

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Henretta, MD

Facility Name

East Carolina University

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frank Parker, MD

Facility Name

UNC Rex Hospital

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Mendes, MD

Facility Name

Oklahoma University Health and VA Medical Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joshua Gierman, MD

Facility Name

Oregon Health and Sciences University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amani Politano, MD

Facility Name

University of Pittsburg Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Singh, MD

Facility Name

Sanford University of South Dakota Medical Center

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57117

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angelo Santos, MD

Facility Name

Cardiothoracic and Vascular Surgeons

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mazin Foteh, MD

Facility Name

Methodist Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlie Cheng, MD

Facility Name

University of Utah Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claire Griffin, MD

Facility Name

Sentara Heart Hospital

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Panneton, MD

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23282

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Newton, MD

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Rossi, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Abdominal Aortic Aneurysm

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial