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Abdominal Aortic AneurysmADVANCENCT05378347

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

A study testing Medtronic Endurant II or Endurant IIs Stent Graft System and Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis in people with Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), run by Medtronic Cardiovascular at 68 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Medtronic Endurant II or Endurant IIs Stent Graft System and Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
68 sitesin 12 countries
Study dates
5 Jan 2023to May 2031
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • 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

Trial locations and contacts

68 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

ADVANCE Trial Clinical Study Team contact

763-514-4000

rs.advancestudy@medtronic.com

68 sites in 12 countries

United States32 sites, 28 recruiting

  • Albany Medical College

    Albany, New York, 12208

    Withdrawn

  • Northside Hospital Forsyth

    Atlanta, Georgia, 30342

    Siddharth Patel

    Recruiting

  • VA Maryland Health Care System

    Baltimore, Maryland, 21201

    Areck Ucuzian, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Marc Schermerhorn, MD

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

    Margaret C Tracci, MD, JD

    Recruiting

  • University Hospitals, Cleveland Medical Center

    Cleveland, Ohio, 44106

    Jae Cho, MD

    Recruiting

  • Denver Health Medical Center

    Denver, Colorado, 80204

    Lisa Bennett, MD, MS

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29615

    Withdrawn

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Rana Afifi, MD

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Young Erben, MD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    William Rothstein, MD

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Ahmed Abou-Zamzam, MD

    Recruiting

  • Cardiovascular Surgery Clinic

    Memphis, Tennessee, 38120

    Withdrawn

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Jeffrey Jim

    Recruiting

  • Yale Center for Clinical Investigation

    New Haven, Connecticut, 06519

    David Kuwayama, MD

    Recruiting

  • Northwell Health Lenox Hill Hospital

    New York, New York, 10075

    Alfio Carroccio, MD

    Recruiting

  • Hoag Hospital

    Newport Beach, California, 92663

    Allen Murga

    Allen Murga

    Recruiting

  • University of California Irvine Medical Center

    Orange, California, 92868

    Anthony Chau, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Grace Wang, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Nathan Liang, MD

    Recruiting

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

    Elyza Guerrero

    Dennis Gable, MD

    Recruiting

  • Maine Medical Center

    Portland, Maine, 04102

    Kristina Giles, MD

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Randall DeMartino, MD

    Recruiting

  • University of California Davis Medical Center

    Sacramento, California, 95817

    Withdrawn

  • University of California San Francisco UCSF Medical Center

    San Francisco, California, 94143

    Jade Hiramoto, MD

    Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

    Jason Wagner, MD

    Recruiting

  • Northshore University Health System

    Skokie, Illinois, 60076

    Cheong Jun Lee, MD

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Matthew Kronick, MD

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Igor Laskowski, MD

    Recruiting

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    William Yoon, MD

    Recruiting

  • Ascension Via Christi Saint Francis

    Wichita, Kansas, 67214

    Chad Ammar, MD

    Recruiting

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

    Phillip Moore, MD

    Recruiting

Other trials in United States

Germany7 sites, 7 recruiting

  • University Hospital Augsburg

    Augsburg, 86156

    Alexander Hyhlik-Duerr, MD, PhD

    Recruiting

  • University Hospital Cologne

    Cologne, 50937

    Bernhard Dorweiler, MD, PhD

    Recruiting

  • Elisabeth Hospital Essen

    Essen, 45138

    Johannes Hoffman, MD

    Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

    Kyriakos Oikonomou, MD, PhD

    Recruiting

  • University Hospital Leipzig

    Leipzig, 04103

    Andrej Schmidt, MD

    Recruiting

  • University Hospital rechts der Isar of the Technical University Munich

    Munich, 81675

    Daniela Branzan, MD

    Recruiting

  • St. Franziskus Hospital Munster

    Münster, 48145

    Martin Austermann, MD

    Recruiting

Other trials in Germany

Japan6 sites, 6 recruiting

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, 078-8510

    Daiki Uchida, MD, PhD

    Recruiting

  • Niigata University Medical and Dental Hospital

    Chuo Ku, Niigata, 951-8510

    Takeshi Okamoto, MD, PhD

    Recruiting

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3125

    Norihiko Shiiya, MD, PhD

    Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

    Hirosho Banno, MD, PhD

    Recruiting

  • Osaka Keisatsu Hospital

    Osaka, 543-8922

    Toru Kuratani

    Recruiting

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-0016

    Hideyuki Shimizu, MD, PhD

    Recruiting

Other trials in Japan

France4 sites, 3 recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    Fabien Thaveau, MD, PhD

    Recruiting

  • Hospices Civils de Lyon-CHU Lyon

    Lyon, 69002

    Withdrawn

  • Assistance Publique - Hopitaux de Marseille Hopital de la Timone

    Marseille, Marseille Cedex, 13385

    Mariangela De Masi, MD

    Recruiting

  • Hopital de Hautepierre - CHU de Strasbourg

    Strasbourg, 67200

    Nabil Chakfe, MD, PhD

    Recruiting

Other trials in France

Netherlands4 sites, 4 recruiting

  • Amsterdam University Medical Center

    Amsterdam

    Kak Khee Yeung

    Recruiting

  • Rijnstate Hospital

    Arnhem, The Netherlands, 6815 AD

    Michel Reijnen, MD, PhD

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

    Philippe Cuypers, MD, PhD

    Recruiting

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

    Hence Verhagen, MD, PhD

    Recruiting

Other trials in Netherlands

Taiwan4 sites, 4 recruiting

  • China Medical University Hospital

    Taichung, 404327

    You-Cian Lin, MD, PhD

    Recruiting

  • Chi Mei Medical Center

    Tainan, 710402

    Nan-Chun Wu, MD

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    I-Hui Wu, MD, PhD

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    I-Ming Chen, MD, PhD

    Recruiting

Other trials in Taiwan

Italy3 sites, 3 recruiting

  • Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico

    Milan, 20122

    Chiara Lomazzi

    Chiara Lomazzi, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

    Umberto Marcello Bracale, MD, PhD

    Recruiting

  • AOU Citta della Salute e della Scienza di Torino

    Torino, 10126

    Fabio Verzini, MD, PhD, FEBVS

    Recruiting

Other trials in Italy

Finland2 sites, 2 recruiting

  • Helsinki University Hospital

    Helsinki, 00290

    Maarit Venermo, MD, PhD

    Recruiting

  • Kuopio University Hospital

    Kuopio, 70200

    Petri Saari, MD

    Recruiting

Other trials in Finland

Switzerland2 sites, 2 recruiting

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

    Sebastien Deglise, MD, PhD

    Recruiting

  • Luzerner Kantonsspital

    Lucerne, 6000

    Maani Hakimi, MD, PhD

    Recruiting

Other trials in Switzerland

United Kingdom2 sites, 2 recruiting

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

    Andrew Tambyraja, MD

    Recruiting

  • Oxford University Hospitals NHS Trust - John Radcliffe Hospital

    Oxford, Oxfordshire, OX3 9DU

    Dominic Howard, BM B.Ch MA DPhil (Oxon) FRCS

    Recruiting

Other trials in United Kingdom

Greece1 site, 1 recruiting

  • University Hospital of Larisa

    Larissa, 41110

    Athanasios Giannoukas, Prof

    Recruiting

Other trials in Greece

Spain1 site, 1 recruiting

  • Hospital Universitario Son Espases

    Palma, Mallorca, 07210

    Pascual Lozano-Vilardell, MD

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.
Being tested
Medtronic Endurant II or Endurant IIs Stent Graft System, Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
Keywords
EVAR, AAA
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Endurant II or Endurant IIs Stent Graft SystemDevice

    EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

  • Gore Excluder or Gore/ Excluder Conformable AAA EndoprosthesisDevice

    EVAR treatment with Excluder / Excluder Conformable Stent Graft System

Study groups in NCT05378347
Study groupRoleWhat they receive
Medtronic Endurant II/IIsExperimentalSubjects 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.
Receives: Device: Medtronic Endurant II or Endurant IIs Stent Graft System
Gore Excluder / Excluder ConformableExperimentalSubjects 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.
Receives: Device: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (6)

  1. Aneurysm sac change by diameter as a continuous variable

    Measured: 12 months and annually to 5 years

  2. Aneurysm sac change by volume incidence rate

    Measured: 12 months and annually to 5 years

  3. Type II endoleak incidence rate

    Measured: 30 days, 12 months and annually to 5 years

  4. Type I endoleak incidence rate

    Measured: 30 days,12 months and annually to 5 years

  5. Secondary intervention incidence rate

    Measured: 30 days, 12 months and annually to 5 years

  6. All cause mortality incidence rate

    Measured: 30 days, 12 months and annually to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start5 Jan 2023
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05378347
Sponsor's protocol ID
MDT21033
Acronym
ADVANCE
Status last verified
Jul 2026
First submitted
12 May 2022
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

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