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Fenestrated TREO Stent-Graft System for Abdominal Aortic Aneurysms

This study is testing a device called the Fenestrated TREO Stent-Graft System to treat abdominal aortic aneurysms (AAA). An AAA is a bulge in the main blood vessel that carries blood from your heart. The study wants to see if this system can successfully treat a specific type of AAA and if it is safe. You might be able to join if you are 18 or older, have a life expectancy greater than 2 years, and have an AAA that is suitable for this type of repair. The study will measure how many patients have serious problems within 30 days and how many have successful aneurysm treatment after 12 months. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is testing the Fenestrated TREO Stent-Graft System.
What's involved
You would have the Fenestrated TREO Stent-Graft System implanted through surgery. You would then have hospital visits for checkups, tests, and scans for 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after the procedure, with key safety and effectiveness measurements taken at 30 days and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07026877

Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

Recruiting
NAAges 18+InterventionalTreatment
Bolton Medical
~20 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Fenestrated TREO Stent Graft System

At a glance

Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with absence of a major adverse event (Primary Safety Endpoint)
Measured over 30-day post-procedure
+2 more outcomes measured

Conditions

Abdominal Aortic Aneurysms (AAA)

Explore related trials

Abdominal Aortic Aneurysm

Where it's being run

7 sites across 7 states
Colorado1
Florida1
Massachusetts1
Missouri1
New York1
Texas1
Washington1

Study leadership

  • Benjamin W Starnes, MD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Lauren Rider
[email protected]
19545470374
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years or older at the time of consent
Life expectancy is greater than 2 years
An abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft and with morphology suitable for endovascular repair (confirmed by Computed Tomography (CT) with contrast performed within 6 months of planned implant procedure) as follows:
Proximal landing zone:
Distal (iliac) landing zone with:
Distal aortic diameter (above the iliac bifurcation) ≥70% of the sum of the iliac limb graft diameters
Minimum 18 mm aortic lumen diameter at the level of the fenestrations
Pathology that requires maximum 5 fenestrations in the main body
Pathology that requires fenestration a minimum 3 mm apart (edge to edge)
Branch vessels (to be bridged to the fenestrated graft) with:
Adequate renal function to tolerate contrast-enhanced CTA
Adequate vascular access compatible with required delivery systems
Willingness to comply with the follow-up evaluation schedule documented in a signed informed consent prior to implant

Exclusion

Pregnant or lactating
Existing endovascular graft in the treated segment intended to be repaired with the Fenestrated TREO Stent-Graft System
Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging.
A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with bridging stent delivery or sealing (as determined by treating physician)
Severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction \<20%, or recent diagnosis of congestive heart failure (CHF; as determined by treating physician).
Stroke or myocardial infarction within 6 months of the planned treatment date
Chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
Chronic Kidney Disease (CKD) stage ≥3b.\*
Active systemic infection or is suspected of having an active systemic infection (e.g., acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV), sepsis)
Clinical conditions that would severely compromise or impair x-ray visualization of the aorta (as determined by treating physician).
History of an aortopathic connective tissue disease (e.g., Marfan's syndrome)
Mycotic aneurysm
Significant or circumferential calcification or mural thrombus (as determined by treating physician):
Cannot receive intraprocedural anticoagulation per the investigator's standard of care, or antiplatelet therapy post-procedurally as per the investigator's standard of care.
Blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair
An investigational study drug or biologic within 30 days of planned procedure or an investigational device within one year of planned procedure or any other treatment that may interfere with the interpretation of the study results.
Medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up.
Untreatable allergy or sensitivity to contrast media, nitinol/nickel, Tantalum, Platinum Iridium (PtIr), 316 stainless steel, ePTFE (expanded polytetrafluoroethylene), PTFE (polytetrafluoroethylene) Impregnated polyester fiber, or polyester
Other major surgical or medical intervention within 45 days of the planned procedure or plan to undergo other major surgical or medical intervention within 45 days post implantation (e.g., coronary artery bypass graft (CABG), organ transplantation, renal stenting)

What this trial measures

  • Proportion of patients with absence of a major adverse event (Primary Safety Endpoint)30-day post-procedure

    The primary safety endpoint is the absence of a major adverse event (MAE) at 30-day post procedure. MAEs are defined as follows: * All-cause mortality, defined as death due to any cause * Myocardial infarction (new onset) based on the Society for Cardiovascular Angiography \& Interventions (SCAI) definition * Respiratory failure requiring prolonged (\>24 hours from anticipated) mechanical ventilation or reintubation * Renal function decline resulting in \>50% reduction from baseline estimated glomerular filtration rate (eGFR) or new-onset dialysis * Bowel ischemia requiring surgical resection or not resolving with medical therapy * Disabling stroke (modified Rankin Scale (mRS) score ≥2 at 90 days post event and an increase in ≥1 mRS category from an individual's pre-stroke baseline, as direct result of the neurological event) * Paraplegia (grade 3, Society for Vascular Surgery (SVS) Thoracic Endovascular Aortic Repair (TEVAR) guidelines)

  • Proportion of patients with successful aneurysm treatment through 12-months post-implant procedure (Primary Effectiveness Endpoint)12 months post-procedure

    The primary effectiveness endpoint is the proportion of patients with successful aneurysm treatment through 12-months post-implant procedure, which is a composite of technical success and absence of the following: * Aneurysm-related mortality: Death occurs within the first 30-days of the index procedure or a secondary intervention, OR any death that results from aneurysm rupture or an aorta-related complication (e.g., implant infection, occlusion, dissection) * Aneurysm rupture: Rupture of the native aneurysm sac (treated lesion) * Type I/III Endoleak * Aneurysm Expansion (\>5 mm) * Migration (\>10 mm) * Loss of patency (i.e., complete occlusion of the aortic implant and/or bridging stent(s)) * Conversion to open surgical repair: Explant of the investigational device due to any cause * Secondary intervention (clinically significant) to address loss of patency, fixation or seal

  • Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components (Technical Success)Evaluated 30-days post procedure

    Composite: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduit without the need for unanticipated corrective intervention related to access * Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components without the need for unanticipated corrective intervention related to delivery and deployment * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels without the need for unanticipated corrective intervention related to placement of the bridging stent(s) * Successful withdrawal of the delivery systems without the need for unanticipated corrective intervention related to withdrawal * Absence of Type I or III endoleaks (assessed by Computed Tomography Angiography, Magnetic Resonance Angiography, or duplex ultrasound) * Patency of all aortic modular stent graft components