ClinicalTrials.gg
Sign In
SuspendedNCT07026877Updated Nov 6, 2026

Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

An interventional study of Fenestrated TREO Stent Graft System in Abdominal Aortic Aneurysms (AAA), sponsored by Bolton Medical. Suspended at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Bolton Medical (part of Terumo Corporation) · Not applicable, Interventional, and Treatment

Why this study was suspended
Voluntary medical device recall of TREO Stent Graft Systems
Updated Nov 6, 2026Now SuspendedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System.

The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm?

Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.

02

Conditions studied

  • Abdominal Aortic Aneurysms (AAA)

Keywords

  • Abdominal Aortic Aneurysm
  • juxtarenal
  • endovascular
03

In context

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's planned enrollment of 20 is below the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

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.

Browse Bolton Medical studies →All Terumo Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 18 years or older at the time of consent
  • 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:

    1. Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or
    2. Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or
    3. Aneurysm with a history of growth > 0.5 cm in 6 months and
    4. Minimum 0 mm of healthy aorta* below the most inferior renal artery that the physician plans on preserving and no renal artery involvement (juxtarenal aneurysms) or
    5. At least one renal artery involved in the aneurysm and minimum 2 mm below the celiac (suprarenal aneurysms) *Healthy aorta is defined as segment of aorta with parallel aortic wall with minimal (\<10%) or no difference in diameter and minimal atherosclerotic debris, thrombus, or calcification.

  • Proximal landing zone:

    1. ≥20 mm length
    2. 20-32 mm diameter
    3. ≤60° angle relative to the axis of the suprarenal aorta
    4. ≤60° angle relative to the long axis of the aneurysm

  • Distal (iliac) landing zone with:

    1. 8-13 mm inside diameter/ ≥10 mm length
    2. >13-20 mm inside diameter/ ≥15 mm length
  • 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:

    1. 5-9 mm diameters
    2. ≥13 mm distal landing zone (or ≥15 mm if there is a gap between fenestration and target vessel)
  • 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 prior to implant

Exclusion criteria

Exclusion Criteria:

  • 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), \<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
  • requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)

  • Chronic Kidney Disease (CKD) stage ≥3b.*

    * During Stage 2, patients with severe CKD (stage ≥3b) can be included in the Expanded Access Arm if otherwise eligible.

  • Active systemic infection or is suspected of having an active systemic infection (e.g., acquired immune deficiency syndrome (AIDS)/ (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):

    1. in the proximal aortic neck
    2. in the distal iliac landing zone
    3. within the treatment length, which may adversely impact device patency
  • 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 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)
Terms in these criteria, in plain language(6)

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Stage 1 - Roll-in Arm

    Minimum of 20 subjects (up to 30) with juxtarenal Abdominal Aortic Aneurysm (AAA), being treated with the Fenestrated TREO Stent-Graft System

    Device: Fenestrated TREO Stent Graft System

Interventions

  • DeviceFenestrated TREO Stent Graft System

    The Fenestrated TREO Stent-Graft System is a modular, endoluminal, over-the-wire system intended for the endovascular treatment of juxtarenal and pararenal to paravisceral aneurysms requiring a fenestrated stent-graft and having suitable morphology. The system is composed of the following components: Fenestrated TREO Bifurcate Stent-Graft - The main body fenestrated bifurcate provides the following; proximal seal, fenestrations and gates for connection to the leg extensions. Bridging Stents - The bridging stent connects the main body bifurcated device to the target visceral artery allowing the target anatomy to maintain perfusion while keeping the pathology sealed TREO Leg and Straight Extension Stent-Grafts: The Leg Extension and Straight Extension stent-grafts are used to complete coverage of the pathology from the main body bifurcated device to the distal landing zones (usually the common iliac artery just proximal to the iliac bifurcation).

06

What researchers measure

Primary outcomes

  1. Proportion of patients with absence of a major adverse event (Primary Safety Endpoint)

    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)

    Time frame: 30-day post-procedure

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

    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

    Time frame: 12 months post-procedure

  3. Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components (Technical Success)

    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

    Time frame: Evaluated 30-days post procedure

Secondary outcomes

  1. All-Cause Mortality

    Individual component of the primary safety endpoint - defined as death due to any cause

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  2. Myocardial Infarction (new onset)

    Individual component of the primary safety endpoint - based on the SCAI definition

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  3. Respiratory failure

    Individual component of the primary safety endpoint - respiratory failure requiring prolonged (\>24 hours from anticipated) mechanical ventilation or reintubation

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  4. Renal function decline

    Individual component of the primary safety endpoint - Renal function decline resulting in \>50% reduction from baseline eGFR or new-onset dialysis

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  5. Bowel ischemia

    Individual component of the primary safety endpoint - Bowel ischemia requiring surgical resection or not resolving with medical therapy

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  6. Disabling stroke

    Individual component of the primary safety endpoint - Disabling stroke (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)

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  7. Paraplegia

    Individual component of the primary safety endpoint -Paraplegia grade 3, as per SVS TEVAR guidelines

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  8. Aneurysm-related mortality

    Individual components of the primary effectiveness endpoint - defined as death which 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)

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  9. Aneurysm rupture

    Individual components of the primary effectiveness endpoint - Rupture of the native aneurysm sac (treated lesion)

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  10. Type I/III Endoleak

    Individual components of the primary effectiveness endpoint - Presence of Type I/IIIEndoleak as confirmed by imaging

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  11. Aneurysm Expansion

    Individual components of the primary effectiveness endpoint - Aneurysm expansion (\>5 mm)

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  12. Device Migration

    Individual components of the primary effectiveness endpoint - Device migration (\>10mm)

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  13. Loss of device patency

    Individual components of the primary effectiveness endpoint - complete occlusion of the aortic implant and/or bridging stent(s)

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  14. Conversion to open surgical repair

    Individual components of the primary effectiveness endpoint - Explant of the investigational device due to any cause

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  15. Secondary intervention (clinically significant) to address loss of patency, fixation or seal

    Individual components of the primary effectiveness endpoint. This includes the following reasons for re-intervention: Loss of Patency: Complete occlusion of the aortic endovascular graft, bridging stent(s), and/or limb(s) Seal: Type Ia/Ib, IIIa/IIIb/IIIc Endoleaks Fixation: Fracture, Kink, Migration Device System Prophylaxis: Device-related Reintervention requiring hospitalization Minor Secondary Interventions will not count against the endpoint and include the following: Endovascular procedures (completed for any reason), specifically percutaneous transluminal angioplasty, atherectomy, stenting without thrombectomy or thrombolysis Interventions to address branch vessel stenosis Interventions to address Type II endoleaks Minor surgical revisions (e.g., patch angioplasty) of the access vessel

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  16. Technical Success (at the index procedure)

    Technical Success (at the index procedure) is a composite of the following: * 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.

    Time frame: At time of index procedure

  17. Presence of endoleak

    Evaluation of the presence of all endoleak types, as confirmed by imaging

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  18. Aneurysm size changes

    Evaluation of changes in aneurysm size. Enlargement is defined as \>5mm, regression is ≥ 5 mm.

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  19. Device Migration Evaluation

    Evaluation of device migration. Migration is defined as \>10mm.

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  20. Patency related observations

    Stenosis and occlusion of the components of the Fenestrated TREO Stent-Graft System

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  21. Loss of device integrity

    Fracture of stent strut, barb, or fenestration ring in Fenestrated TREO, fracture of stent in any Fenestrated TREO system implant

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  22. Target vessel instability

    Target vessel instability is a composite endpoint consisting of the following side branch complications: * Death related to side branch complication(s) * Rupture related to side branch complication(s) * Secondary intervention to address a side branch-related complication

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  23. Secondary interventions related to the device/treated lesion

    Any secondary interventions that are performed that are related to the device or the treated lesion will be recorded.

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  24. Target vessel complications

    Including dissection and/or perforation

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  25. Access-related complications

    Access-related complications

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  26. Serious Adverse Events

    As per protocol definition

    Time frame: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.

  27. Operative metrics - Time

    Information relating to the time of the surgical procedure such as start time, stop time, duration of procedure (min) and length of endovascular time (min)

    Time frame: Perioperative

  28. Operative metrics - Number of Vessels intended to be Perfused via Fenestrated TREO Fenestrations

    Information relating to the number and name of the vessels to be perfused via the Fenestrated TREO Fenestrations

    Time frame: Evaluated at time of implant

  29. Operative metrics - Mechanism of access

    Information relating to the mechanism of access for the endovascular procedure

    Time frame: Evaluated at time of implant

  30. Radiation Exposure - Fluoroscopy Time

    Fluoroscopy time (min)

    Time frame: Evaluated at time of implant

  31. Radiation Exposure - Total volume of Contrast

    Volume of contrast used during procedure measured in mL

    Time frame: Evaluated at time of implant

07

Study locations

7 sites
08

References and documents

Publications

  • Starnes BW, Zettervall S, Larimore A, Singh N. Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms. Ann Surg. 2024 Oct 1;280(4):633-639. doi: 10.1097/SLA.0000000000006422. Epub 2024 Jun 26. PubMed 38920026 ↗
  • Tinelli G, Sica S, Sobocinski J, Ribreau Z, de Waure C, Ferraresi M, Snider F, Tshomba Y, Haulon S. Long-Term Propensity-Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair of Complex Abdominal Aortic Aneurysms. J Endovasc Ther. 2024 Dec;31(6):1208-1217. doi: 10.1177/15266028231162256. Epub 2023 Mar 28. PubMed 36978269 ↗
  • Deery SE, Lancaster RT, Baril DT, Indes JE, Bertges DJ, Conrad MF, Cambria RP, Patel VI. Contemporary outcomes of open complex abdominal aortic aneurysm repair. J Vasc Surg. 2016 May;63(5):1195-200. doi: 10.1016/j.jvs.2015.12.038. PubMed 27109792 ↗
  • Locham S, Dakour-Aridi H, Bhela J, Nejim B, Bhavana Challa A, Malas M. Thirty-Day Outcomes of Fenestrated and Chimney Endovascular Repair and Open Repair of Juxtarenal, Pararenal, and Suprarenal Abdominal Aortic Aneurysms Using National Surgical Quality Initiative Program Database (2012-2016). Vasc Endovascular Surg. 2019 Apr;53(3):189-198. doi: 10.1177/1538574418819284. Epub 2018 Dec 26. PubMed 30587096 ↗
  • Meuli L, Kaufmann YL, Lattmann T, Attigah N, Dick F, Mujagic E, Papazoglou DD, Weiss S, Wyss TR, Zimmermann A. Editor's Choice - Peri-operative Mortality and Morbidity of Complex Abdominal Aortic Aneurysm Repair in Switzerland: A Swissvasc Report. Eur J Vasc Endovasc Surg. 2025 Jan;69(1):25-35. doi: 10.1016/j.ejvs.2024.06.022. Epub 2024 Jun 19. PubMed 38906370 ↗
  • Latz CA, Boitano L, Schwartz S, Swerdlow N, Dansey K, Varkevisser RRB, Patel V, Schermerhorn ML. Editor's Choice - Mortality is High Following Elective Open Repair of Complex Abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2021 Jan;61(1):90-97. doi: 10.1016/j.ejvs.2020.09.002. Epub 2020 Oct 9. PubMed 33046385 ↗
  • Michel M, Becquemin JP, Clement MC, Marzelle J, Quelen C, Durand-Zaleski I; WINDOW Trial Participants. Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):189-96. doi: 10.1016/j.ejvs.2015.04.012. Epub 2015 Jun 19. PubMed 26100447 ↗
  • Inker LA, Astor BC, Fox CH, Isakova T, Lash JP, Peralta CA, Kurella Tamura M, Feldman HI. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis. 2014 May;63(5):713-35. doi: 10.1053/j.ajkd.2014.01.416. Epub 2014 Mar 16. PubMed 24647050 ↗
  • Vaidya SR, Aeddula NR. Chronic Renal Failure. In: StatPearls. Treasure Island (FL): StatPearls Publishing, http://www.ncbi.nlm.nih.gov/books/NBK535404/ (2023, accessed 18 September 2023)
  • Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013 Oct 22;62(17):1563-70. doi: 10.1016/j.jacc.2013.08.720. PubMed 24135581 ↗
  • Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL; Society for Vascular Surgery Ad Hoc Committee on TEVAR Reporting Standards. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg. 2010 Oct;52(4):1022-33, 1033.e15. doi: 10.1016/j.jvs.2010.07.008. No abstract available. PubMed 20888533 ↗
  • Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, Matsumura JS, May J, Veith FJ, Fillinger MF, Rutherford RB, Kent KC; Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1048-60. doi: 10.1067/mva.2002.123763. No abstract available. PubMed 12021727 ↗
  • Zettervall SL, Starnes BW. Planning and sizing of fenestrated/branched stent grafts. Semin Vasc Surg. 2022 Sep;35(3):252-258. doi: 10.1053/j.semvascsurg.2022.07.006. Epub 2022 Aug 6. PubMed 36153066 ↗
  • Lott A, Reiter JP. Wilson Confidence Intervals for Binomial Proportions With Multiple Imputation for Missing Data. The American Statistician 2020; 74: 109-115.
  • Raulli SJ, Gomes VC, Parodi FE, Vasan P, Sun D, Marston WA, Pascarella L, McGinigle KL, Wood JC, Farber MA. Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent. J Vasc Surg. 2024 Aug;80(2):302-310. doi: 10.1016/j.jvs.2024.04.017. Epub 2024 Apr 10. PubMed 38608964 ↗
  • Hemingway JF, Starnes BW, Kline BR, Singh N. Initial experience with the Terumo aortic Treo device for fenestrated endovascular aneurysm repair. J Vasc Surg. 2021 Sep;74(3):823-831.e1. doi: 10.1016/j.jvs.2021.01.042. Epub 2021 Feb 14. PubMed 33592291 ↗
  • Nguyen T, Gittinger M, Gryzbowski C, Patel S, Asirwatham M, Grundy S, Zwiebel B, Shames M, Arnaoutakis DJ. One-hundred Consecutive Physician-Modified Fenestrated Endovascular Aneurysm Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using the Terumo TREO Stent Graft. Ann Vasc Surg. 2024 Sep;106:369-376. doi: 10.1016/j.avsg.2024.04.009. Epub 2024 May 31. PubMed 38823478 ↗
  • Yeung KK, Nederhoed JH, Tran BL, Di Gregorio S, Pratesi G, Bastianon M, Melani C, Riambau V, Bloemert-Tuin T, Hazenberg CEVB, van Herwaarden JA, Balm R, Lely RJ, van der Meijs BB, Blankensteijn JD, Hoksbergen AWJ, Jongkind V. Endovascular Repair of Juxtarenal and Pararenal Abdominal Aortic Aneurysms Using a Novel Low-Profile Fenestrated Custom-Made Endograft: Technical Details and Short-Term Outcomes. J Endovasc Ther. 2025 Dec;32(6):1988-1993. doi: 10.1177/15266028241227392. Epub 2024 Jan 30. PubMed 38288587 ↗
  • Eagleton MJ, Stoner M, Henretta J, Dryjski M, Panneton J, Tassiopoulos A, Mehta M, Pearce B, Sharafuddin MJ; TREO Investigators. Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms. J Vasc Surg. 2021 Jul;74(1):114-123.e3. doi: 10.1016/j.jvs.2020.10.083. Epub 2020 Nov 28. PubMed 33253871 ↗
  • Oderich GS, Forbes TL, Chaer R, Davies MG, Lindsay TF, Mastracci T, Singh MJ, Timaran C, Woo EY; Writing Committee Group. Reporting standards for endovascular aortic repair of aneurysms involving the renal-mesenteric arteries. J Vasc Surg. 2021 Jan;73(1S):4S-52S. doi: 10.1016/j.jvs.2020.06.011. Epub 2020 Jun 29. PubMed 32615285 ↗

Individual participant data

Plan to share: No — Publications and presentations referring to the study will be coordinated by a Study Publication Committee overseen by the Sponsor. This committee will be responsible for the following activities: determining the scope of each publication; reviewing data provided by the Biostatistician; writing scientific papers or preparing presentation; submitting papers for publication or abstracts for conference/congress presentations. Decisions on IPD sharing will be taken as part of the study publication process.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Suspended Voluntary medical device recall of TREO Stent Graft Systems
changed Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Suspended
    Why stopped Voluntary medical device recall of TREO Stent Graft Systems
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07026877
Lead sponsor
Bolton Medical
Responsible party
Sponsor
First posted
Jun 18, 2025
Start date
Nov 18, 2025
Primary completion
May 29, 2027 (estimated)
Completion
May 29, 2030 (estimated)
Last update
Nov 6, 2026

Study contacts

Benjamin W Starnes, MD
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aortic Aneurysm, Abdominal →

Other studies from this sponsor

Bolton Medical →

Start the discussion