Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
NCT ID: NCT05378347
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
550 participants
INTERVENTIONAL
2023-01-05
2031-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Medtronic Endurant II/IIs
Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.
Medtronic Endurant II or Endurant IIs Stent Graft System
EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
Gore Excluder / Excluder Conformable
Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.
Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
EVAR treatment with Excluder / Excluder Conformable Stent Graft System
Interventions
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Medtronic Endurant II or Endurant IIs Stent Graft System
EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
EVAR treatment with Excluder / Excluder Conformable Stent Graft System
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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 has an estimated life expectancy of ≤ 3 years as judged by the investigator
* Subject has an aneurysm that is:
1. Suprarenal/pararenal/juxtarenal
2. Isolated ilio-femoral
3. Mycotic
4. Inflammatory
5. Pseudoaneurysm
6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries
7. Ruptured
8. 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
20 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Schermerhorn, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center, United States
Hence Verhagen, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus University Medical Center, Netherlands
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Hoag Hospital
Newport Beach, California, United States
University of California Irvine Medical Center
Orange, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco UCSF Medical Center
San Francisco, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Northside Hospital Forsyth
Atlanta, Georgia, United States
Northshore University Health System
Skokie, Illinois, United States
Ascension Via Christi Saint Francis
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
VA Maryland Health Care System
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Albany Medical College
Albany, New York, United States
Northwell Health Lenox Hill Hospital
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Cardiovascular Surgery Clinic
Memphis, Tennessee, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Helsinki University Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Assistance Publique - Hopitaux de Marseille Hopital de la Timone
Marseille, Marseille Cedex, France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Hospices Civils de Lyon-CHU Lyon
Lyon, , France
Hopital de Hautepierre - CHU de Strasbourg
Strasbourg, , France
University Hospital Augsburg
Augsburg, , Germany
University Hospital Cologne
Cologne, , Germany
Elisabeth Hospital Essen
Essen, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
University Hospital Leipzig
Leipzig, , Germany
University Hospital rechts der Isar of the Technical University Munich
Munich, , Germany
St. Franziskus Hospital Munster
Münster, , Germany
University Hospital of Larisa
Larissa, , Greece
Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
AOU Citta della Salute e della Scienza di Torino
Torino, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Niigata University Medical and Dental Hospital
Chuo Ku, Niigata, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Rijnstate Hospital
Arnhem, The Netherlands, Netherlands
Amsterdam University Medical Center
Amsterdam, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Hospital Universitario Son Espases
Palma, Mallorca, Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Allen Murga
Role: primary
Siddharth Patel
Role: primary
Jeffrey Jim
Role: primary
Elyza Guerrero
Role: primary
Athanasios Giannoukas, Prof
Role: primary
Chiara Lomazzi
Role: primary
Kak Khee Yeung
Role: primary
Other Identifiers
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MDT21033
Identifier Type: -
Identifier Source: org_study_id
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