Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

Официальное название

A Prospective, Multicenter, Non-Blinded, Non-Randomized Pivotal Study of the Fenestrated TREO Stent-Graft System in Subjects With Abdominal Aortic Aneurysms Requiring a Fenestrated Graft and Suitable for Endovascular Repair

Обзор

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.

Вмешательства

• Устройство Fenestrated 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 -

Первичные конечные точки

• Proportion of patients with absence of a major adverse event (Primary Safety Endpoint) [Срок оценки: 30-day post-procedure]
• Proportion of patients with successful aneurysm treatment through 12-months post-implant procedure (Primary Effectiveness Endpoint) [Срок оценки: 12 months post-procedure]
• Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components (Technical Success) [Срок оценки: Evaluated 30-days post procedure]

Вторичные конечные точки (12)

• All-Cause Mortality [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]
• Disabling stroke [Срок оценки: 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.]
• Paraplegia [Срок оценки: 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.]
• Aneurysm-related mortality [Срок оценки: 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.]
• Aneurysm rupture [Срок оценки: 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.]
• Type I/III Endoleak [Срок оценки: 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.]
• Aneurysm Expansion [Срок оценки: 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.]
• Device Migration [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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:

• 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
• 20-32 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:

• 8-13 mm inside diameter/ ≥10 mm length
• >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:

• 5-9 mm diameters
• ≥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 informed consent prior to implant

Критерии исключения

• 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):

• in the proximal aortic neck
• in the distal iliac landing zone
• 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 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• UC Health Memorial — Colorado Springs
• Tampa General Hospital — Tampa
• Brigham and Women's Hospital — Boston
• Washington University School of Medicine — St Louis
• Mt. Sinai — New York
• Baylor Scott and White Research Institute — Plano
• University of Washington Medical Center — Seattle

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 24647050

Идентификаторы

NCT: NCT07026877 · IP-0022-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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