Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

NCT05378347 | Recruiting FDA Device

• 1 other identifier: MDT21033
• Study Type: interventional
• Target: 600
• Locations: 12 countries
• Sites: 68

Brief 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.

Conditions

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

Keywords

EVAR, AAA

Outcome Measures

Primary Outcomes (1)

• Sac Regression

  Proportion of patients with sac regression at 1 year, defined in accordance with SVS guidelines as the reduction in maximum diameter by \>= 5 mm when compared to the first CT imaging study obtained within 90 days after index procedure.

  12 months

Secondary Outcomes (6)

• Aneurysm sac change by diameter as a continuous variable

  12 months and annually to 5 years

• Aneurysm sac change by volume incidence rate

  12 months and annually to 5 years

• Type II endoleak incidence rate

  30 days, 12 months and annually to 5 years

• Type I endoleak incidence rate

  30 days,12 months and annually to 5 years

• Secondary intervention incidence rate

  30 days, 12 months and annually to 5 years

Study Arms (2)

Medtronic Endurant II/IIs

EXPERIMENTAL

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.

Device: Medtronic Endurant II or Endurant IIs Stent Graft System

Gore Excluder / Excluder Conformable

EXPERIMENTAL

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.

Device: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

Interventions

Medtronic Endurant II or Endurant IIs Stent Graft System DEVICE

EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

Medtronic Endurant II/IIs

Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis DEVICE

EVAR treatment with Excluder / Excluder Conformable Stent Graft System

Gore Excluder / Excluder Conformable

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Suprarenal/pararenal/juxtarenal
• Isolated ilio-femoral
• Mycotic
• Inflammatory
• Pseudoaneurysm
• Concomitant or prior dissection involving the abdominal aorta or iliac arteries
• Ruptured
• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (68)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Hoag Hospital

Newport Beach, California, 92663, United States

RECRUITING

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

University of California Davis Medical Center

Sacramento, California, 95817, United States

WITHDRAWN

University of California San Francisco UCSF Medical Center

San Francisco, California, 94143, United States

RECRUITING

Denver Health Medical Center

Denver, Colorado, 80204, United States

RECRUITING

Yale Center for Clinical Investigation

New Haven, Connecticut, 06519, United States

RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Northside Hospital Forsyth

Atlanta, Georgia, 30342, United States

RECRUITING

Northshore University Health System

Skokie, Illinois, 60076, United States

RECRUITING

Ascension Via Christi Saint Francis

Wichita, Kansas, 67214, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Albany Medical College

Albany, New York, 12208, United States

WITHDRAWN

Northwell Health Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29615, United States

WITHDRAWN

Cardiovascular Surgery Clinic

Memphis, Tennessee, 38120, United States

WITHDRAWN

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Kuopio University Hospital

Kuopio, 70200, Finland

RECRUITING

Assistance Publique - Hopitaux de Marseille Hopital de la Timone

Marseille, Marseille Cedex, 13385, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Hospices Civils de Lyon-CHU Lyon

Lyon, 69002, France

WITHDRAWN

Hopital de Hautepierre - CHU de Strasbourg

Strasbourg, 67200, France

RECRUITING

University Hospital Augsburg

Augsburg, 86156, Germany

RECRUITING

University Hospital Cologne

Cologne, 50937, Germany

RECRUITING

Elisabeth Hospital Essen

Essen, 45138, Germany

RECRUITING

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

RECRUITING

University Hospital Leipzig

Leipzig, 04103, Germany

RECRUITING

University Hospital rechts der Isar of the Technical University Munich

Munich, 81675, Germany

RECRUITING

St. Franziskus Hospital Munster

Münster, 48145, Germany

RECRUITING

University Hospital of Larisa

Larissa, 41110, Greece

RECRUITING

Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

RECRUITING

AOU Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

RECRUITING

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 078-8510, Japan

RECRUITING

Niigata University Medical and Dental Hospital

Chuo Ku, Niigata, 951-8510, Japan

RECRUITING

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3125, Japan

RECRUITING

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-0016, Japan

RECRUITING

Osaka Keisatsu Hospital

Osaka, 543-8922, Japan

RECRUITING

Rijnstate Hospital

Arnhem, The Netherlands, 6815 AD, Netherlands

RECRUITING

Amsterdam University Medical Center

Amsterdam, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

RECRUITING

Hospital Universitario Son Espases

Palma, Mallorca, 07210, Spain

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

China Medical University Hospital

Taichung, 404327, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, 710402, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

RECRUITING

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Marc Schermerhorn, MD

  Beth Israel Deaconess Medical Center, United States

  PRINCIPAL INVESTIGATOR

• Hence Verhagen, MD

  Erasmus University Medical Center, Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ADVANCE Trial Clinical Study Team

CONTACT

763-514-4000; rs.advancestudy@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical Events Committee members as well as key sponsor team members will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: January 5, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

GR (1); NL (4); CH (2); GB (2); TW (4); ES (1); US (32); FI (2); FR (4); JP (6); IT (3); DE (7)