Ensayos clínicos

Inclusion Criteria:

- Subject and the treating physician agree that the subject will return for all required followup visits.

- Subject or legal representative or consultee, as applicable, has consented for study 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).

- Subject's AAA anatomy is appropriate for both 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 study.

- 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, including leaking;

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. Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites.

- 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 treatment for abdominal aortic aneurysm.

- Planned use of aorto-uni-iliac (AUI) main body device.

- Any planned additional device during index procedure (e.g., endostaple or anchor, Iliac branch endoprosthesis, sac or side branch embolization etc.).

- Subject has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m^2 or subject is on dialysis.

- Subject has a systemic infection who may be at increased risk of endovascular graft infection.

- Subject has a psychiatric or other condition that may interfere with the study.

- Subject is a female 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.

Eligibility last updated 7/19/22. Questions regarding updates should be directed to the study team contact.