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NCT05378347NARecruiting

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Medtronic Cardiovascular

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

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

Interventions

DEVICE

Medtronic Endurant II or Endurant IIs Stent Graft System

DEVICE

Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

Interested in This Trial?

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Conditions

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

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