Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression
Status: Recruiting
Location: See all (67) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• Subject and the treating physician agree that the subject will return for all required followup 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)
• 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.
Locations
United States
California
Loma Linda University Medical Center
RECRUITING
Loma Linda
Hoag Hospital
RECRUITING
Newport Beach
University of California Irvine Medical Center
RECRUITING
Orange
University of California Davis Medical Center
WITHDRAWN
Sacramento
University of California San Francisco UCSF Medical Center
RECRUITING
San Francisco
Colorado
Denver Health Medical Center
RECRUITING
Denver
Connecticut
Yale Center for Clinical Investigation
RECRUITING
New Haven
Washington, D.c.
Medstar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Sarasota Memorial Hospital
RECRUITING
Sarasota
Georgia
Northside Hospital Forsyth
RECRUITING
Atlanta
Illinois
Northshore University Health System
RECRUITING
Skokie
Kansas
Ascension Via Christi Saint Francis
RECRUITING
Wichita
Kentucky
University of Kentucky
RECRUITING
Lexington
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Baystate Medical Center
RECRUITING
Springfield
Maryland
VA Maryland Health Care System
RECRUITING
Baltimore
Maine
Maine Medical Center
RECRUITING
Portland
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
Novant Health Forsyth Medical Center
RECRUITING
Winston-salem
New York
Albany Medical College
RECRUITING
Albany
Northwell Health Lenox Hill Hospital
RECRUITING
New York
Westchester Medical Center
RECRUITING
Valhalla
Ohio
University Hospitals, Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
South Carolina
Prisma Health
WITHDRAWN
Greenville
Tennessee
Cardiovascular Surgery Clinic
WITHDRAWN
Memphis
Texas
University of Texas Health Science Center at Houston
RECRUITING
Houston
The Heart Hospital Baylor Plano
RECRUITING
Plano
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Kuopio University Hospital
RECRUITING
Kuopio
France
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
Hospices Civils de Lyon-CHU Lyon
WITHDRAWN
Lyon
Assistance Publique - Hopitaux de Marseille Hopital de la Timone
RECRUITING
Marseille
Hopital de Hautepierre - CHU de Strasbourg
RECRUITING
Strasbourg
Germany
University Hospital Augsburg
RECRUITING
Augsburg
University Hospital Cologne
RECRUITING
Cologne
Elisabeth Hospital Essen
RECRUITING
Essen
Universitatsklinikum Frankfurt
RECRUITING
Frankfurt
University Hospital Leipzig
RECRUITING
Leipzig
University Hospital rechts der Isar of the Technical University Munich
RECRUITING
Munich
St. Franziskus Hospital Munster
RECRUITING
Münster
Greece
University Hospital of Larisa
RECRUITING
Larissa
Italy
Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
AOU Citta della Salute e della Scienza di Torino
RECRUITING
Torino
Japan
Asahikawa Medical University Hospital
RECRUITING
Asahikawa
Niigata University Medical and Dental Hospital
RECRUITING
Chuo Ku
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Nagoya University Hospital
RECRUITING
Nagoya
Keio University Hospital
RECRUITING
Shinjuku-ku
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Rijnstate Hospital
RECRUITING
Arnhem
Catharina Ziekenhuis
RECRUITING
Eindhoven
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Spain
Hospital Universitario Son Espases
RECRUITING
Palma
Switzerland
Centre Hospitalier Universitaire Vaudois
RECRUITING
Lausanne
Luzerner Kantonsspital
RECRUITING
Lucerne
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Chi Mei Medical Center
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
RECRUITING
Oxford
Contact Information
Primary
ADVANCE Trial Clinical Study Team
rs.advancestudy@medtronic.com
763-514-4000
Time Frame
Start Date: 2023-01-05
Estimated Completion Date: 2031-05
Participants
Target number of participants: 550
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular