Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT05378347

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Led by Medtronic Cardiovascular · Updated on 2026-04-08

600

Participants Needed

68

Research Sites

434 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject and the treating physician agree that the subject will return for all required follow up visits
  • Subject or legal representative or consultee has consented for trial participation and signed the approved Informed Consent
  • Subject has an aneurysm diameter of 25 5 cm if woman, or 25 5.5 cm if man, or as stated 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 per physician and Core Lab assessment following applicable IFUs
Not Eligible

You will not qualify if you...

  • Subject is in an investigational drug or device study that may affect this trial
  • Subject has an estimated life expectancy of 24 3 years
  • Subject has an aneurysm that is suprarenal/pararenal/juxtarenal, isolated ilio-femoral, mycotic, inflammatory, pseudoaneurysm, concomitant or prior dissection of abdominal aorta or iliac arteries, ruptured, or symptomatic AAA
  • Subject has significant thrombus or calcium at implantation sites with thrombus 25 2 mm thick or 25 25% vessel circumference in seal zone
  • Subject requires emergent aneurysm treatment such as trauma or rupture
  • Subject has connective tissue disease causing aneurysm (e.g., Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome)
  • Subject has had prior surgical or endovascular treatment in abdominal aorta or iliac arteries for aneurysm or occlusive disease
  • Planned use of aorto-uni-iliac main body device
  • Planned additional devices during procedure beyond main body, limb stent graft, and extensions
  • Planned coverage of internal iliac artery/arteries
  • Subject has eGFR < 45 ml/min/1.73m2 or is on dialysis
  • Subject has systemic infection increasing risk of graft infection
  • Subject has psychiatric or other conditions interfering with trial
  • Subject is of childbearing potential without excluded pregnancy
  • Subject has known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media not amenable to pre-treatment
  • Subject is considered vulnerable by investigator
  • Subject has active COVID-19 infection or relevant COVID-19 history

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 68 locations

1

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

Actively Recruiting

2

Hoag Hospital

Newport Beach, California, United States, 92663

Actively Recruiting

3

University of California Irvine Medical Center

Orange, California, United States, 92868

Actively Recruiting

4

University of California Davis Medical Center

Sacramento, California, United States, 95817

Withdrawn

5

University of California San Francisco UCSF Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

6

Denver Health Medical Center

Denver, Colorado, United States, 80204

Actively Recruiting

7

Yale Center for Clinical Investigation

New Haven, Connecticut, United States, 06519

Actively Recruiting

8

Medstar Washington Hospital Center

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

Actively Recruiting

9

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

Actively Recruiting

10

Sarasota Memorial Hospital

Sarasota, Florida, United States, 34239

Actively Recruiting

11

Northside Hospital Forsyth

Atlanta, Georgia, United States, 30342

Actively Recruiting

12

Northshore University Health System

Skokie, Illinois, United States, 60076

Actively Recruiting

13

Ascension Via Christi Saint Francis

Wichita, Kansas, United States, 67214

Actively Recruiting

14

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

15

Maine Medical Center

Portland, Maine, United States, 04102

Actively Recruiting

16

VA Maryland Health Care System

Baltimore, Maryland, United States, 21201

Actively Recruiting

17

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

18

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

19

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

20

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

21

Albany Medical College

Albany, New York, United States, 12208

Withdrawn

22

Northwell Health Lenox Hill Hospital

New York, New York, United States, 10075

Actively Recruiting

23

Westchester Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

24

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

25

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

26

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

27

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

28

Prisma Health

Greenville, South Carolina, United States, 29615

Withdrawn

29

Cardiovascular Surgery Clinic

Memphis, Tennessee, United States, 38120

Withdrawn

30

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

31

The Heart Hospital Baylor Plano

Plano, Texas, United States, 75093

Actively Recruiting

32

University of Virginia Health System

Charlottesville, Virginia, United States, 22908

Actively Recruiting

33

Helsinki University Hospital

Helsinki, Finland, 00290

Actively Recruiting

34

Kuopio University Hospital

Kuopio, Finland, 70200

Actively Recruiting

35

Assistance Publique - Hopitaux de Marseille Hopital de la Timone

Marseille, Marseille Cedex, France, 13385

Actively Recruiting

36

CHU Clermont-Ferrand

Clermont-Ferrand, France, 63003

Actively Recruiting

37

Hospices Civils de Lyon-CHU Lyon

Lyon, France, 69002

Withdrawn

38

Hopital de Hautepierre - CHU de Strasbourg

Strasbourg, France, 67200

Actively Recruiting

39

University Hospital Augsburg

Augsburg, Germany, 86156

Actively Recruiting

40

University Hospital Cologne

Cologne, Germany, 50937

Actively Recruiting

41

Elisabeth Hospital Essen

Essen, Germany, 45138

Actively Recruiting

42

Universitatsklinikum Frankfurt

Frankfurt, Germany, 60590

Actively Recruiting

43

University Hospital Leipzig

Leipzig, Germany, 04103

Actively Recruiting

44

University Hospital rechts der Isar of the Technical University Munich

Munich, Germany, 81675

Actively Recruiting

45

St. Franziskus Hospital Munster

Münster, Germany, 48145

Actively Recruiting

46

University Hospital of Larisa

Larissa, Greece, 41110

Actively Recruiting

47

Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico

Milan, Italy, 20122

Actively Recruiting

48

Azienda Ospedaliera Universitaria Federico II

Naples, Italy, 80131

Actively Recruiting

49

AOU Citta della Salute e della Scienza di Torino

Torino, Italy, 10126

Actively Recruiting

50

Nagoya University Hospital

Nagoya, Aichi-ken, Japan, 466-8560

Actively Recruiting

51

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan, 078-8510

Actively Recruiting

52

Niigata University Medical and Dental Hospital

Chuo Ku, Niigata, Japan, 951-8510

Actively Recruiting

53

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan, 431-3125

Actively Recruiting

54

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan, 160-0016

Actively Recruiting

55

Osaka Keisatsu Hospital

Osaka, Japan, 543-8922

Actively Recruiting

56

Rijnstate Hospital

Arnhem, The Netherlands, Netherlands, 6815 AD

Actively Recruiting

57

Amsterdam University Medical Center

Amsterdam, Netherlands

Actively Recruiting

58

Catharina Ziekenhuis

Eindhoven, Netherlands, 5623 EJ

Actively Recruiting

59

Erasmus Medisch Centrum

Rotterdam, Netherlands, 3015 GD

Actively Recruiting

60

Hospital Universitario Son Espases

Palma, Mallorca, Spain, 07210

Actively Recruiting

61

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland, 1011

Actively Recruiting

62

Luzerner Kantonsspital

Lucerne, Switzerland, 6000

Actively Recruiting

63

China Medical University Hospital

Taichung, Taiwan, 404327

Actively Recruiting

64

Chi Mei Medical Center

Tainan, Taiwan, 710402

Actively Recruiting

65

National Taiwan University Hospital

Taipei, Taiwan, 10002

Actively Recruiting

66

Taipei Veterans General Hospital

Taipei, Taiwan, 112201

Actively Recruiting

67

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

68

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom, EH16 4SA

Actively Recruiting

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Research Team

A

ADVANCE Trial Clinical Study Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial | DecenTrialz