Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Start Date
1/5/2023
Completion Date
5/1/2031
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.
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.
Eligibility Criteria
Age Range: 20 years to No maximum
Interventions
Medtronic Endurant II or Endurant IIs Stent Graft System
Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
Conditions
Locations
Loma Linda University Medical Center
Loma Linda, California 92354
United States
Hoag Hospital
Newport Beach, California 92663
United States
University of California Irvine Medical Center
Orange, California 92868
United States
University of California Davis Medical Center
Sacramento, California 95817
United States
University of California San Francisco UCSF Medical Center
San Francisco, California 94143
United States
Denver Health Medical Center
Denver, Colorado 80204
United States
Yale Center for Clinical Investigation
New Haven, Connecticut 06519
United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Sarasota Memorial Hospital
Sarasota, Florida 34239
United States
Northside Hospital Forsyth
Atlanta, Georgia 30342
United States
Northshore University Health System
Skokie, Illinois 60076
United States
Ascension Via Christi Saint Francis
Wichita, Kansas 67214
United States
University of Kentucky
Lexington, Kentucky 40536
United States
Maine Medical Center
Portland, Maine 04102
United States
VA Maryland Health Care System
Baltimore, Maryland 21201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Baystate Medical Center
Springfield, Massachusetts 01199
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Albany Medical College
Albany, New York 12208
United States
Northwell Health Lenox Hill Hospital
New York, New York 10075
United States
Westchester Medical Center
Valhalla, New York 10595
United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio 44106
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
Prisma Health
Greenville, South Carolina 29615
United States
Cardiovascular Surgery Clinic
Memphis, Tennessee 38120
United States
University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
The Heart Hospital Baylor Plano
Plano, Texas 75093
United States
University of Virginia Health System
Charlottesville, Virginia 22908
United States
Helsinki University Hospital
Helsinki, 00290
Finland
Kuopio University Hospital
Kuopio, 70200
Finland
Assistance Publique - Hopitaux de Marseille Hopital de la Timone
Marseille, Marseille Cedex 13385
France
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
France
Hospices Civils de Lyon-CHU Lyon
Lyon, 69002
France
Hopital de Hautepierre - CHU de Strasbourg
Strasbourg, 67200
France
University Hospital Augsburg
Augsburg, 86156
Germany
University Hospital Cologne
Cologne, 50937
Germany
Elisabeth Hospital Essen
Essen, 45138
Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590
Germany
University Hospital Leipzig
Leipzig, 04103
Germany
University Hospital rechts der Isar of the Technical University Munich
Munich, 81675
Germany
St. Franziskus Hospital Munster
Münster, 48145
Germany
University Hospital of Larisa
Larissa, 41110
Greece
Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico
Milan, 20122
Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Italy
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Italy
Nagoya University Hospital
Nagoya, Aichi-ken 466-8560
Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido 078-8510
Japan
Niigata University Medical and Dental Hospital
Chuo Ku, Niigata 951-8510
Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka 431-3125
Japan
Keio University Hospital
Shinjuku-Ku, Tokyo 160-0016
Japan
Osaka Keisatsu Hospital
Osaka, 543-8922
Japan
Rijnstate Hospital
Arnhem, The Netherlands 6815 AD
Netherlands
Amsterdam University Medical Center
Amsterdam,
Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Netherlands
Hospital Universitario Son Espases
Palma, Mallorca 07210
Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Switzerland
Luzerner Kantonsspital
Lucerne, 6000
Switzerland
China Medical University Hospital
Taichung, 404327
Taiwan
Chi Mei Medical Center
Tainan, 710402
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Taipei Veterans General Hospital
Taipei, 112201
Taiwan
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
Oxford, Oxfordshire OX3 9DU
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
United Kingdom