Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Inclusion Criteria:

• Subject and the treating physician agree that the subject will return for allrequired followup visits

• Subject or legal representative or consultee, as applicable, has consented for trialparticipation and signed the Informed Consent approved by the sponsor and by theEthics Committee/Institutional Review Board

• Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man)

• Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent GraftSystem and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessmentof both treating physician and Core Lab in accordance with the overlappingcommercially available IFUs per applicable region.

Exclusion Criteria:

• Subject is participating in an investigational drug or device study which may biasor 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 implantationsites, 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. Marfansyndrome, Ehlers-Danlos, Loeys-Dietz syndrome

• Subject has previously undergone surgical or endovascular treatment in the abdominalaorta 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 andextensions per assigned treatment per randomization) during index or stagedprocedure, 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 orsubject is on dialysis

• Subject has a systemic infection who may be at increased risk of endovascular graftinfection, per investigator's discretion

• Subject has a psychiatric or other condition that may interfere with the trial, perinvestigator'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