Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

Inclusion Criteria:

• 18 years or older at the time of consent

• Life expectancy is greater than 2 years

• An abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft and withmorphology suitable for endovascular repair (confirmed by Computed Tomography (CT)with contrast performed within 6 months of planned implant procedure) as follows:

1. Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or

2. Maximum AAA diameter exceeding two times the normal diameter just proximal tothe aneurysm using orthogonal (i.e., perpendicular to the centerline)measurements (or saccular aneurysm that warrants treatment in the opinion ofthe investigator) or

3. Aneurysm with a history of growth > 0.5 cm in 6 months and

4. Minimum 0 mm of healthy aorta* below the most inferior renal artery that thephysician plans on preserving and no renal artery involvement (juxtarenalaneurysms) or

5. At least one renal artery involved in the aneurysm and minimum 2 mm below theceliac (suprarenal aneurysms) *Healthy aorta is defined as segment of aortawith parallel aortic wall with minimal (<10%) or no difference in diameter andminimal atherosclerotic debris, thrombus, or calcification.

• Proximal landing zone:

1. ≥20 mm length

2. 20-32 mm diameter

3. ≤60° angle relative to the axis of the suprarenal aorta

4. ≤60° angle relative to the long axis of the aneurysm

• Distal (iliac) landing zone with:

1. 8-13 mm inside diameter/ ≥10 mm length

2. >13-20 mm inside diameter/ ≥15 mm length

• Distal aortic diameter (above the iliac bifurcation) ≥70% of the sum of the iliaclimb graft diameters

• Minimum 18 mm aortic lumen diameter at the level of the fenestrations

• Pathology that requires maximum 5 fenestrations in the main body

• Pathology that requires fenestration a minimum 3 mm apart (edge to edge)

• Branch vessels (to be bridged to the fenestrated graft) with:

1. 5-9 mm diameters

2. ≥13 mm distal landing zone (or ≥15 mm if there is a gap between fenestrationand target vessel)

• Adequate renal function to tolerate contrast-enhanced CTA

• Adequate vascular access compatible with required delivery systems

• Willingness to comply with the follow-up evaluation schedule documented in a signedinformed consent prior to implant

Exclusion Criteria:

• Pregnant or lactating

• Existing endovascular graft in the treated segment intended to be repaired with theFenestrated TREO Stent-Graft System

• Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (asdetermined by treating physician)

• Implant procedure as planned does not allow for at least one patent hypogastricartery left intact, unless both are occluded on pre-op imaging.

• A branch vessel(s) that is dissected or has significant calcification, tortuosity,thrombus formation that would interfere with bridging stent delivery or sealing (asdetermined by treating physician)

• Severe untreated coronary artery disease and/or unstable angina, significant areasof myocardium at risk (based on coronary angiogram or radionuclide scans), leftventricular ejection fraction <20%, or recent diagnosis of congestive heart failure (CHF; as determined by treating physician).

• Stroke or myocardial infarction within 6 months of the planned treatment date

• Chronic obstructive pulmonary disease requiring routine need for oxygen therapyoutside the hospital setting (e.g., daily or nightly home use)

• Chronic Kidney Disease (CKD) stage ≥3b.*

• During Stage 2, patients with severe CKD (stage ≥3b) can be included in theExpanded Access Arm if otherwise eligible.

• Active systemic infection or is suspected of having an active systemic infection (e.g., acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV), sepsis)

• Clinical conditions that would severely compromise or impair x-ray visualization ofthe aorta (as determined by treating physician).

• History of an aortopathic connective tissue disease (e.g., Marfan's syndrome)

• Mycotic aneurysm

• Significant or circumferential calcification or mural thrombus (as determined bytreating physician):

1. in the proximal aortic neck

2. in the distal iliac landing zone

3. within the treatment length, which may adversely impact device patency

• Cannot receive intraprocedural anticoagulation per the investigator's standard ofcare, or antiplatelet therapy post-procedurally as per the investigator's standardof care.

• Blood coagulation disorder or bleeding diathesis, the treatment for which cannot besuspended pre- and post-repair

• An investigational study drug or biologic within 30 days of planned procedure or aninvestigational device within one year of planned procedure or any other treatmentthat may interfere with the interpretation of the study results.

• Medical, social or psychological issues that the investigator believes may interferewith study treatment or follow-up.

• Untreatable allergy or sensitivity to contrast media, nitinol/nickel, Tantalum,Platinum Iridium (PtIr), 316 stainless steel, ePTFE (expandedpolytetrafluoroethylene), PTFE (polytetrafluoroethylene) Impregnated polyesterfiber, or polyester

• Other major surgical or medical intervention within 45 days of the planned procedureor plan to undergo other major surgical or medical intervention within 45 days postimplantation (e.g., coronary artery bypass graft (CABG), organ transplantation,renal stenting)