Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1)

Inclusion Criteria:

1. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires
proximal graft placement in Zone 0-2.

2. Age ≥18 years at time of informed consent signature

3. Subject is capable of complying with protocol requirements, including follow-up

4. Informed Consent Form (ICF) is signed by Subject or legal representative

5. Must have appropriate proximal aortic landing zone.

6. Must have appropriate target branch vessel landing zone.

7. For patients with aneurysm/isolated lesion, must have appropriate distal aortic
landing zone.

8. Native aortic valve (Zone 0/1 subjects only)

9. Subject is considered a high risk candidate for conventional open surgical repair at
the discretion of the Investigator (Zone 0/1 subjects only)

Exclusion Criteria:

1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta
requiring repair

2. Previous endovascular repair of the ascending aorta

3. Previous endovascular repair of the DTA with a non-Gore device

4. Surgery within 30 days prior to enrollment, with the exception of surgery for
Ascending Aortic Dissection and/or placement of vascular conduit for access.

5. Infected aorta

6. Life expectancy <2 years

7. Myocardial infarction within 6 weeks prior to treatment

8. Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing
clinical signs of focal (or global) disturbance of cerebral function, lasting more
than 24 hours or leading to death, with no apparent cause other than that of vascular
origin.

9. Patient has a systemic infection and may be at increased risk of endovascular graft
infection

10. Pregnant female at time of informed consent signature

11. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome

12. Participation in another drug or medical device study within one year of study
enrollment

13. Known history of drug abuse within one year of treatment

14. Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or
ascending aorta

15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath
insertion and the inability to use a conduit for vascular access

16. Planned coverage of celiac artery

17. Patient has known sensitivities or allergies to the device materials

18. Patient has known hypersensitivity or contraindication to anticoagulants or contrast
media, which is not amenable to pre-treatment

19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known
hypersensitivity to heparin

20. Patient with a history of a hypercoagulability disorder and/or hypercoagulability
state

21. Diameter taper outside of the device sizing range between proximal and distal landing
zones of aorta and the inability to use additional devices of different diameters to
compensate for the taper

22. Mycotic aneurysm

23. Persistent refractory shock (systolic blood pressure <90 mm Hg)

24. Patient has body habitus or other medical condition which prevents adequate
visualization of the aorta

25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR)
<30 or currently requiring dialysis

26. Patient at high risk of neurological event, e.g. stroke