Recruiting

Endurant II/IIs vs. Gore Excluder

Sponsor:

Medtronic Cardiovascular

Code:

NCT05378347

Conditions

Abdominal Aortic Aneurysm

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

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

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Medtronic Endurant II or Endurant IIs Stent Graft System

Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

Study Details

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)

Study ID

NCT05378347

Start date

Jan 5, 2023

Status verified date

Jul, 2026

Completion date

May, 2031

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medtronic Endurant II/IIs

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.

experimental: Gore Excluder / Excluder Conformable

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.

Interventions

Medtronic Endurant II or Endurant IIs Stent Graft System

EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

EVAR treatment with Excluder / Excluder Conformable Stent Graft System

Primary outcome measure

  • Sac Regression [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

ADVANCE Trial Clinical Study Team

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

Locations

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Principal Investigator:

Ahmed Abou-Zamzam, MD

Hoag Hospital

Recruiting

Newport Beach, California, United States, 92663

Principal Investigator:

Allen Murga

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Principal Investigator:

Anthony Chau, MD

University of California San Francisco UCSF Medical Center

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Jade Hiramoto, MD

Denver Health Medical Center

Recruiting

Denver, Colorado, United States, 80204

Principal Investigator:

Lisa Bennett, MD, MS

Yale Center for Clinical Investigation

Recruiting

New Haven, Connecticut, United States, 06519

Principal Investigator:

David Kuwayama, MD

Medstar Washington Hospital Center

Recruiting

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

Principal Investigator:

William Yoon, MD

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Young Erben, MD

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Principal Investigator:

Jason Wagner, MD

Northside Hospital Forsyth

Recruiting

Atlanta, Georgia, United States, 30342

Northshore University Health System

Recruiting

Skokie, Illinois, United States, 60076

Principal Investigator:

Cheong Jun Lee, MD

Ascension Via Christi Saint Francis

Recruiting

Wichita, Kansas, United States, 67214

Principal Investigator:

Chad Ammar, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

William Rothstein, MD

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Principal Investigator:

Kristina Giles, MD

VA Maryland Health Care System

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Areck Ucuzian, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Marc Schermerhorn, MD

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Principal Investigator:

Matthew Kronick, MD

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Randall DeMartino, MD

Northwell Health Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Principal Investigator:

Alfio Carroccio, MD

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Principal Investigator:

Igor Laskowski, MD

Novant Health Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Principal Investigator:

Phillip Moore, MD

University Hospitals, Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Jae Cho, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Grace Wang, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Principal Investigator:

Nathan Liang, MD

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Rana Afifi, MD

The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

Principal Investigator:

Dennis Gable, MD

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Margaret C Tracci, MD, JD

More Information

Sponsor

Medtronic Cardiovascular

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • EVAR, AAA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic Cardiovascular on 2026-07-06.