Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Официальное название

Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression

Обзор

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

Подробное описание

This is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm clinical trial. The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis in standard EVAR subjects. Subjects are randomized on a 1:1 basis to receive EVAR with either a Medtronic Endurant II/IIs Stent Graft Systems or Gore Excluder / Excluder Conformable AAA Endoprosthesis. Data is collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Approximately 600 subjects are planned to be enrolled at up to 100 sites globally.

Product Names:

* Medtronic Endurant II/IIs Stent Graft System * Gore Excluder and/or Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives.

Вмешательства

• Устройство Medtronic Endurant II or Endurant IIs Stent Graft System
  EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
• Устройство Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
  EVAR treatment with Excluder / Excluder Conformable Stent Graft System

Первичные конечные точки

• Sac Regression [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Aneurysm sac change by diameter as a continuous variable [Срок оценки: 12 months and annually to 5 years]
• Aneurysm sac change by volume incidence rate [Срок оценки: 12 months and annually to 5 years]
• Type II endoleak incidence rate [Срок оценки: 30 days, 12 months and annually to 5 years]
• Type I endoleak incidence rate [Срок оценки: 30 days,12 months and annually to 5 years]
• Secondary intervention incidence rate [Срок оценки: 30 days, 12 months and annually to 5 years]
• All cause mortality incidence rate [Срок оценки: 30 days, 12 months and annually to 5 years]

Критерии участия

Критерии включения

• Subject and the treating physician agree that the subject will return for all required follow up visits
• Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board
• Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.
• Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.

Критерии исключения

• Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
• Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
• Subject has an aneurysm that is:

• Suprarenal/pararenal/juxtarenal
• Isolated ilio-femoral
• Mycotic
• Inflammatory
• Pseudoaneurysm
• Concomitant or prior dissection involving the abdominal aorta or iliac arteries
• Ruptured
• Symptomatic AAA
• Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck.
• Subject requires emergent aneurysm treatment, for example, trauma or rupture
• Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
• Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease
• Planned use of aorto-uni-iliac (AUI) main body device
• Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch endoprosthesis, embolization, etc.
• Planned coverage of the internal iliac artery/arteries
• Subject has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 or subject is on dialysis
• Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion
• Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion
• Subject is of childbearing potential in whom pregnancy cannot be excluded
• Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
• Subject belongs to a vulnerable population per investigator's judgment
• Subject has an active COVID-19 infection or relevant history of COVID- 19

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 32 центра

• Loma Linda University Medical Center — Loma Linda
• Hoag Hospital — Newport Beach
• University of California Irvine Medical Center — Orange
• University of California Davis Medical Center — Sacramento
• University of California San Francisco UCSF Medical Center — San Francisco
• Denver Health Medical Center — Denver
• Yale Center for Clinical Investigation — New Haven
• Medstar Washington Hospital Center — Washington D.C.
• … и ещё 24 центра

Германия · 7 центров

• University Hospital Augsburg — Augsburg
• University Hospital Cologne — Cologne
• Elisabeth Hospital Essen — Essen
• Universitatsklinikum Frankfurt — Frankfurt
• University Hospital Leipzig — Leipzig
• University Hospital rechts der Isar of the Technical University Munich — Munich
• St. Franziskus Hospital Munster — Münster

Япония · 6 центров

• Nagoya University Hospital — Nagoya
• Asahikawa Medical University Hospital — Asahikawa
• Niigata University Medical and Dental Hospital — Chuo Ku
• Hamamatsu University Hospital — Hamamatsu
• Keio University Hospital — Shinjuku-Ku
• Osaka Keisatsu Hospital — Osaka

Франция · 4 центра

• Assistance Publique - Hopitaux de Marseille Hopital de la Timone — Marseille
• CHU Clermont-Ferrand — Clermont-Ferrand
• Hospices Civils de Lyon-CHU Lyon — Lyon
• Hopital de Hautepierre - CHU de Strasbourg — Strasbourg

Нидерланды · 4 центра

• Rijnstate Hospital — Arnhem
• Amsterdam University Medical Center — Amsterdam
• Catharina Ziekenhuis — Eindhoven
• Erasmus Medisch Centrum — Rotterdam

Тайвань · 4 центра

• China Medical University Hospital — Taichung
• Chi Mei Medical Center — Tainan
• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Италия · 3 центра

• Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico — Milan
• Azienda Ospedaliera Universitaria Federico II — Naples
• AOU Citta della Salute e della Scienza di Torino — Torino

Финляндия · 2 центра

• Helsinki University Hospital — Helsinki
• Kuopio University Hospital — Kuopio

Швейцария · 2 центра

• Centre Hospitalier Universitaire Vaudois — Lausanne
• Luzerner Kantonsspital — Lucerne

Великобритания · 2 центра

• Oxford University Hospitals NHS Trust - John Radcliffe Hospital — Oxford
• Royal Infirmary of Edinburgh — Edinburgh

Греция · 1 центр

• University Hospital of Larisa — Larissa

Испания · 1 центр

• Hospital Universitario Son Espases — Palma

Идентификаторы

NCT: NCT05378347 · MDT21033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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