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Recruiting NCT05378347

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

No phase Interventional Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder) Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medtronic Endurant II or Endurant IIs Stent Graft System, Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis.
Who it may be relevant to
Registry conditions: Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder). Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Finland, France, Germany, Greece +7
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Sac Regression [Time frame: 12 months]
Secondary outcome measures (6)
  • Aneurysm sac change by diameter as a continuous variable [Time frame: 12 months and annually to 5 years]
  • Aneurysm sac change by volume incidence rate [Time frame: 12 months and annually to 5 years]
  • Type II endoleak incidence rate [Time frame: 30 days, 12 months and annually to 5 years]
  • Type I endoleak incidence rate [Time frame: 30 days,12 months and annually to 5 years]
  • Secondary intervention incidence rate [Time frame: 30 days, 12 months and annually to 5 years]
  • All cause mortality incidence rate [Time frame: 30 days, 12 months and annually to 5 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 32 centers
  • 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.
  • … and 24 more centers
Germany · 7 centers
  • 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
Japan · 6 centers
  • 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
France · 4 centers
  • 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
Netherlands · 4 centers
  • Rijnstate Hospital — Arnhem
  • Amsterdam University Medical Center — Amsterdam
  • Catharina Ziekenhuis — Eindhoven
  • Erasmus Medisch Centrum — Rotterdam
Taiwan · 4 centers
  • China Medical University Hospital — Taichung
  • Chi Mei Medical Center — Tainan
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
Italy · 3 centers
  • Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico — Milan
  • Azienda Ospedaliera Universitaria Federico II — Naples
  • AOU Citta della Salute e della Scienza di Torino — Torino
Finland · 2 centers
  • Helsinki University Hospital — Helsinki
  • Kuopio University Hospital — Kuopio
Switzerland · 2 centers
  • Centre Hospitalier Universitaire Vaudois — Lausanne
  • Luzerner Kantonsspital — Lucerne
United Kingdom · 2 centers
  • Oxford University Hospitals NHS Trust - John Radcliffe Hospital — Oxford
  • Royal Infirmary of Edinburgh — Edinburgh
Greece · 1 center
  • University Hospital of Larisa — Larissa
Spain · 1 center
  • Hospital Universitario Son Espases — Palma

Identifiers

NCT: NCT05378347 · MDT21033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗