Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Trial details

Who runs it

Medtronic Cardiovascular

Trial code

NCT05378347

Record updated

6 July 2026

Original description

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 full original descriptionShow less

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.

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 aneurysm that is:; Suprarenal/pararenal/juxtarenal; Isolated ilio-femoral; Mycotic; Inflammatory; Pseudoaneurysm; Concomitant or prior dissection involving the abdominal aorta or iliac arteries; Ruptured; Symptomatic AAA; Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease; Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome; 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 has an active COVID-19 infection or relevant history of COVID- 19; 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 has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 or subject is on dialysis; Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment; Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator; Subject requires emergent aneurysm treatment, for example, trauma or rupture; 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 is of childbearing potential in whom pregnancy cannot be excluded; Subject belongs to a vulnerable population per investigator's judgment.

ClinicalTrials.gov NCT05378347