Clinical trial NCT04697784: Post-Approval Study of the TREO Abdominal Stent-Graft System
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
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: AAA
Abdominal Aortic Aneurysm
TREO
EVAR
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Abdominal Aortic Aneurysm Stent-Graft
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.
timeFrame: Through 5 Years post-procedure
measure: Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation.
timeFrame: Through 5 Years post-procedure
Secondary outcomes:
measure: Number of participants with technical success at the conclusion of the index procedure
timeFrame: Through 5 Years post-procedure
measure: Major Adverse Events
timeFrame: Through 5 Years post-procedure
measure: Incidence of procedure-related clinical utility measures
timeFrame: Through 5 Years post-procedure
measure: Incidence of procedure-related complications
timeFrame: Through 5 Years post-procedure
measure: Incidence of successful aneurysm treatment
timeFrame: 12 months post-implant
measure: Incidence of all-cause mortality
timeFrame: Through 5 Years post-procedure
measure: Incidence of aneurysm-related mortality
timeFrame: Through 5 Years post-procedure
measure: Incidence of aneurysm rupture
timeFrame: Through 5 Years post-procedure
measure: Incidence of secondary interventions.
timeFrame: Through 5 Years post-procedure
measure: Incidence of conversion to open surgical repair.
timeFrame: Through 5 Years post-procedure
measure: Incidence of stent-graft occlusion (i.e., loss of patency)
timeFrame: Through 5 Years post-procedure
measure: Incidence of device stenosis or kink
timeFrame: Through 5 Years post-procedure
measure: Incidence of loss of device integrity
timeFrame: Through 5 Years post-procedure
measure: Incidence of aneurysm enlargement (>5mm as compared to 30-day imaging).
timeFrame: Through 5 Years post-procedure
measure: Incidence of stent-graft migration (>10mm as compared to 30-day imaging)
timeFrame: Through 5 Years post-procedure
measure: Incidence of Type I, II, III, IV or V Endoleaks
timeFrame: Through 5 Years post-procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Hospital
state: California
city: San Diego
country: United States
facility: VA San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Tampa
country: United States
facility: University of South Florida / Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinic
state: Iowa
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay Region
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute / Abbott Northwestern Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital at Washington University
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Sisters of Charity Hospital, Catholic Health System
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital / Northwell Health
state: New York
city: Rochester
country: United States
facility: University of Rochester -- Strong Memorial Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Health
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Raleigh
country: United States
facility: UNC Rex Hospital
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma University Health and VA Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford University of South Dakota Medical Center
state: South Dakota
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: