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ADVANCE Trial: Comparing Stent Grafts for Abdominal Aortic Aneurysms

This study, called the ADVANCE Trial, is comparing two different stent graft systems used to treat abdominal aortic aneurysms (a bulging in the main artery of your belly). It's looking at the Medtronic Endurant II/IIs Stent Graft System versus the Gore Excluder/Excluder Conformable AAA Endoprosthesis. The goal is to see which system leads to better "sac regression," meaning the aneurysm shrinks, after 12 months. You might be able to join if you are an adult with an abdominal aortic aneurysm that is at least 5.5 centimeters if you are male, or 5.0 centimeters if you are female. The current recruitment status is unclear, but the study plans to enroll about 600 people.

Study design
This is a randomized study, meaning you would be assigned to receive one of the two stent graft systems by chance. It is a global study involving multiple centers and plans to enroll approximately 600 participants.
What's involved
You would need to agree to return for all required follow-up visits. Data is collected before and after the procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 5 years after your procedure, with annual visits to collect data.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05378347

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Recruiting
NAAges 20+InterventionalTreatment
Medtronic Cardiovascular
~600 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Medtronic Endurant II or Endurant IIs Stent Graft SystemGore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

At a glance

Recruiting sites
63 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sac Regression
Measured over 12 months

Conditions

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

Explore related trials

Abdominal Aortic Aneurysm

Where it's being run

68 sites across 40 states
Germany7
California5
Taiwan4
New York3
France3
Italy3
Netherlands3
Florida2

Study leadership

  • Marc Schermerhorn, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center, United States
  • Hence Verhagen, MD · PRINCIPAL_INVESTIGATOR · Erasmus University Medical Center, Netherlands

Who to contact

ADVANCE Trial Clinical Study Team
[email protected]
763-514-4000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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

What this trial measures

  • Sac Regression12 months

    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.