RecruitingNot ApplicableNCT05378347

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

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

Sponsor

Medtronic Cardiovascular

Enrollment

600 participants

Start Date

Jan 5, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis and a medical device called Medtronic Endurant II or Endurant IIs Stent Graft System for people with abdominal aortic aneurysm, abdominal aortic aneurysm >= 5.0 centimeters in female (disorder), and other related conditions. The study is currently recruiting participants at 68 locations. People eligible for this study include aged 20 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMedtronic Endurant II or Endurant IIs Stent Graft System

EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

DEVICEGore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

EVAR treatment with Excluder / Excluder Conformable Stent Graft System

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

View Full Details on ClinicalTrials.gov

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