An interventional study of TREO Abdominal Stent-Graft System in Abdominal Aortic Aneurysm, sponsored by Bolton Medical. Active, not recruiting at 40 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Bolton Medical (part of Terumo Corporation) · Not applicable, Interventional, and Treatment
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.
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 338 is above the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Bolton Medical is the lead sponsor of 14 studies on the registry; none are open to participants now.
First submitted after Bolton Medical became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: Through 5 Years post-procedure
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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-implant
Incidence of all-cause mortality
Rate of mortality attributed to any causality as confirmed by the CEC.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 5 Years post-procedure
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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