Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05378347

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Sponsor: Medtronic Cardiovascular

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2023-01-05

Completion Date

2031-05

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)

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

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: 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

Locations (68)

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

Naples, 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

Osaka Keisatsu Hospital

Osaka, 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, 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