Actively Recruiting
Endurant Stent Graft System vs Gore Excluder Endoprosthesis: A Global, Prospective, Randomized Clinical Trial Evaluating Sac Regression in Abdominal Aortic Aneurysm
Led by Medtronic Cardiovascular · Updated on 2026-04-08
600
Participants Needed
68
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating key performance outcomes of two stent graft systems—the Medtronic Endurant II/IIs and the Gore Excluder/Excluder Conformable AAA Endoprosthesis—in people with abdominal aortic aneurysms (AAA). The goal is to compare sac regression outcomes and other important measures to better understand how these devices perform after endovascular aneurysm repair (EVAR). This global, multi-center, randomized trial involves subjects who have aneurysms suitable for treatment with either device. Participants are randomly assigned to receive EVAR using either the Medtronic Endurant II/IIs Stent Graft System or the Gore Excluder/Excluder Conformable device. Data is gathered before and after the procedure at hospital discharge, 30 days post-procedure, and annually for up to five years. Imaging studies are collected at all follow-up times and reviewed by a central core lab to assess the primary and secondary outcomes. Throughout the study, participants will undergo various evaluations including imaging to measure aneurysm sac size and volume changes, and monitoring for complications such as endoleaks or need for additional interventions. Researchers will also track mortality rates and other safety outcomes. The total follow-up period lasts five years with scheduled visits to collect consistent data on device performance and participant health.
CONDITIONS
Brief Title
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject and treating physician agree the subject will attend all required follow-up visits
- Subject or legal representative has signed informed consent approved by sponsor and ethics boards
- Aneurysm diameter of at least 5 cm for women or 5.5 cm for men, or as per regional guidelines
- AAA anatomy suitable for both Medtronic Endurant II/IIs and Gore Excluder devices, confirmed by physician and Core Lab
You will not qualify if you...
- Participation in another investigational drug or device study that could affect trial outcomes
- Estimated life expectancy of 3 years or less
- Aneurysm types: suprarenal, pararenal, juxtarenal, isolated ilio-femoral, mycotic, inflammatory, pseudoaneurysm, prior or current dissection, ruptured, or symptomatic AAA
- Significant thrombus or calcium (≥2 mm thickness or ≥25% vessel circumference) at arterial implantation sites
- Need for emergency aneurysm treatment such as trauma or rupture
- Connective tissue diseases like Marfan, Ehlers-Danlos, Loeys-Dietz syndromes
- Previous surgical or endovascular abdominal aorta or iliac artery treatment
- Planned use of aorto-uni-iliac main body device or additional devices beyond assigned treatment
- Planned coverage of internal iliac arteries
- Estimated glomerular filtration rate (eGFR) below 45 ml/min/1.73m2 or dialysis
- Systemic infection increasing graft infection risk
- Psychiatric or other conditions interfering with trial participation
- Childbearing potential where pregnancy cannot be excluded
- Known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media
- Vulnerable populations as judged by investigator
- Active COVID-19 infection or relevant history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo endovascular aneurysm repair (EVAR) using either the Medtronic Endurant II/IIs Stent Graft System or the Gore Excluder / Excluder Conformable AAA Endoprosthesis.
1 procedure visit
Duration - Up to 5 years
Participants are followed with imaging and clinical assessments to monitor aneurysm sac regression and potential complications after the EVAR procedure.
Visits at discharge, 30 days, and annually up to 5 years
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
Research Team
A
ADVANCE Trial Clinical Study Team
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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