Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

NCT07026877 | Recruiting DMC FDA Device

• 1 other identifier: IP-0022-24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Abdominal Aortic Aneurysms (AAA)

Keywords

Abdominal Aortic Aneurysm; juxtarenal; endovascular

Outcome Measures

Primary Outcomes (3)

• 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)

  30-day post-procedure

• 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

  12 months post-procedure

• 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

  Evaluated 30-days post procedure

Secondary Outcomes (31)

• All-Cause Mortality

  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.

• Myocardial Infarction (new onset)

  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.

• Respiratory failure

  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.

• Renal function decline

  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.

• Bowel ischemia

  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.

Study Arms (1)

Stage 1 - Roll-in Arm

EXPERIMENTAL

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

Fenestrated TREO Stent Graft System DEVICE

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).

Stage 1 - Roll-in Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or
• 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
• Aneurysm with a history of growth \> 0.5 cm in 6 months and
• 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
• 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:
• ≥20 mm length
• mm diameter
• ≤60° angle relative to the axis of the suprarenal aorta
• ≤60° angle relative to the long axis of the aneurysm
• Distal (iliac) landing zone with:
• mm inside diameter/ ≥10 mm length

You may not qualify if:

• 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.\*
• \* 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)/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):

Sponsors & Collaborators

• Bolton Medical: lead

Study Sites (7)

UC Health Memorial

Colorado Springs, Colorado, 80909, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

NOT YET RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Mt. Sinai

New York, New York, 10019, United States

ACTIVE NOT RECRUITING

Baylor Scott and White Research Institute

Plano, Texas, 75093, United States

ACTIVE NOT RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (20)

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• 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.

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• 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.

  PMID: 30587096 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Benjamin W Starnes, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Rider

CONTACT

19545470374; L.rider@terumoaortic.com

Valerie Merkle

CONTACT

+1 954 838 9699; v.merkle@terumoaortic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 18, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): May 29, 2027
• Study Completion (Estimated): May 29, 2030
• Last Updated: February 18, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)