Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

1. Aortic aneurysm involving the visceral vessels requiring treatment defined as at leasthe following:
   • Fusiform aneurysm diameter ≥ 5 cm
   • Saccular aneurysm (no diameter requirement)
   • Rapid aneurysm growth (≥ 5 mm in one year)
2. Aortic aneurysm that involves the abdominal aorta, with:
   • Involvement of at least one visceral vessel and aneurysmal extension as far as 65he celiac artery, and/or
   • No normal aorta between the upper extent of aneurysm and renal artery(s)
3. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial
   arteries as required)
4. Age ≥ 19 years at the time of informed consent signature
5. Male or infertile female
6. Patient assessment favors an endovascular approach when compared to open surgicaldeemed by the treating physician
7. Capable of complying with protocol requirements, including follow-up
8. An Informed Consent Form signed by Subject or legal representative
9. Sufficient distal landing zones in both iliac arteries, with at least one patenty and without planned placement of a branched iliac device, ord coverage/occlusion/embolization of any patent internal iliac artery.
10. Appropriate aortic anatomy to receive the TAMBE Device defined as all of thewing
    • For the TAMBE aortic component, proximal aortic landing zone diameters between22-34 mm
    • Proximal seal zone ≥ 20 mm in length
    • Aortic neck angle ≤ 60°
    • Distal landing zone (iliac arteries) 8-25 mm
    • Distal seal zone in iliac arteries of at least 10 mm in length
    • Renal artery landing zone diameters between 4-10 mm
    • Celiac and superior mesenteric artery landing zone diameters between 5-12 mm
    • ≥ 15 mm landing zone in each branch vessel
    • Landing zones in the proximal and distal aorta and all branch vessels cannot beurysmal, heavily calcified, or heavily thrombosed
    • Patent left subclavian artery

11. If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a
       CTAG Device is required. The aortic landing zone diameter treatment range with the
       CTAG Device is 19.5-32 mm
     12. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left
       subclavian artery.
     13. The most proximal aortic device seal zone will be within native aorta or a
       previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another
       device manufacturer's stent graft will not be supported
    Exclusion Criteria:
    The patient is / has:
     1. Prior open, aortic surgery of the ascending aorta or aortic arch
     2. Ruptured or leaking aortic aneurysm
     3. Aneurysmal dilatation due to chronic aortic dissection
     4. Infected aorta
     5. Mycotic aneurysm
     6. Life expectancy <2 years
     7. Myocardial infarction or stroke within 1 year of treatment (staged or index procedure)
     8. Systemic infection which may increase risk of endovascular graft infection
     9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
     10. Participation in an investigational drug study (within 30 days of last administration)
       or investigational medical device study (within 1 year of implant) from the time of
       study screening
     11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of
       treatment
     12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a
       conduit for vascular access
     13. A branch vessel(s) that is dissected or has significant calcification, tortuosity,
       thrombus formation that would interfere with device delivery or ability to exclude
       from blood flow
     14. Known sensitivities or allergies to the device materials
     15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known
       hypersensitivity to heparin
     16. Patient has body habitus or other medical condition which prevents adequate
       fluoroscopic and CT visualization of the aorta
     17. Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing
       dialysis)
     18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to
       require surgical intervention within one year of study treatment