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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: TREO Abdominal Stent-Graft System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Abdominal Aortic Aneurysm Stent-Graft
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects who receive the TREO Abdominal Stent-Graft System<br>Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System. | Device: TREO Abdominal Stent-Graft System<br>* The TREO Abdominal Stent-Graft System is intended for the treatment of infrarenal abdominal aortic aneurysms with or without iliac involvement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Incidence of all-cause mortality | Rate of mortality attributed to any causality as confirmed by the CEC. | Through 5 Years post-procedure | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAA, Abdominal Aortic Aneurysm, TREO, EVAR