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

Abdominal Aortic Aneurysm Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04697784
• Other study ID #: IP-0021-20
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: July 31, 2027

Study information

• Verified date: September 2023
• Source: Bolton Medical
• Contact: Gretchen Wild
• Phone: 954-779-6393
• Email: g.wild[@]terumoaortic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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.

Locations

Country	Name	City	State
United States	Mission Health	Asheville	North Carolina
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Colorado Anschutz	Aurora	Colorado
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	McLaren Bay Region	Bay City	Michigan
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Sisters of Charity Hospital, Catholic Health System	Buffalo	New York
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida	Gainesville	Florida
United States	East Carolina University	Greenville	North Carolina
United States	Methodist Hospital	Houston	Texas
United States	University of Iowa Hospital and Clinic	Iowa City	Iowa
United States	University of California, San Diego	La Jolla	California
United States	Long Beach Memorial Hospital	Long Beach	California
United States	Mount Sinai Medical Center	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute / Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Rutgers Robert Wood Johnson Medical Center	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Lenox Hill Hospital / Northwell Health	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Sentara Heart Hospital	Norfolk	Virginia
United States	Oklahoma University Health and VA Medical Center	Oklahoma City	Oklahoma
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	Banner University Medical Center	Phoenix	Arizona
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon
United States	UNC Rex Hospital	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester -- Strong Memorial Hospital	Rochester	New York
United States	Barnes Jewish Hospital at Washington University	Saint Louis	Missouri
United States	University of Utah Hospital	Salt Lake City	Utah
United States	VA San Diego	San Diego	California
United States	Sanford University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	Stony Brook Medical Center	Stony Brook	New York
United States	University of South Florida / Tampa General Hospital	Tampa	Florida
United States	Pima Heart and Vascular	Tucson	Arizona
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bolton Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of all-cause mortality	Rate of mortality attributed to any causality as confirmed by the CEC.	Through 5 Years post-procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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