Evaluation of the GORE® Ascending Stent Graft

Inclusion Criteria: ASG Device Alone Arm

The patient is/has:

1. Ascending Aortic pathologies warranting surgical repair compatible with thetreatment requirements of the ASG device meeting any of the following criteria:Aneurysm

2. Fusiform aneurysm (≥50mm or documented growth rate >0.5cm/year)

3. Saccular aneurysm (no diameter criteria)

4. Pseudoaneurysms (>30 days post-surgery, no diameter criteria) Non-aneurysm

5. Penetrating Aortic Ulcers (PAUs) (no diameter criteria)

6. Pseudoaneurysms, following open surgical repair of a Type A dissection (>30days post-surgery, no diameter criteria)

7. Anatomic compatibility with ASG device based on Gore Imaging Sciences review.

8. Treatment must be limited to the ascending aorta

9. Lesion location is ≥2cm distal to the most distal coronary artery ostia

≥2cm proximal to the origin of theBrachiocephalic Artery (BCA)

4. Proximal and distal landing zones must be ≥2cm in length

5. Landing zones cannot be heavily calcified, or heavily thrombosed

6. Landing zone diameter between 27mm - 48mm

7. For patients with prior replacement of the ascending aorta and/or aortic archby an endovascular or surgical graft, there must be at least ≥2 cm overlap ofASG device and previously implanted graft.

8. Considered high-risk for open surgical repair by meeting any of the followingcriteria:

9. ≥75 years of age

10. Previous median sternotomy

11. Documented identification of other subject-specific risk factors (e.g., medicalhistory, active medical diagnosis) by a study investigator and an experiencedopen ascending and/or aortic arch surgeon (e.g., cardiothoracic surgeon).

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

13. Adequate vascular access via transfemoral or retroperitoneal approach

14. Informed Consent Form (ICF) signed by the subject or legally authorizedrepresentative

15. Agrees to comply with protocol requirements, including imaging and 5-year follow-up

Exclusion Criteria: ASG Device Alone Arm

The patient is/has:

1. De novo Type A dissection

2. Requires immediate treatment

3. Dissected great vessels requiring treatment

4. Anticipated need for coronary or aortic valve intervention within one year posttreatment

5. Any aortic valve repair or replacement including transcatheter aortic valvereplacement (TAVR) or coronary artery intervention within 30 days prior to treatment

6. Complex percutaneous coronary intervention (PCI) or treatment for acute coronarysyndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior totreatment

7. Open chest surgical repair within 30 days prior to treatment

8. Presence of Intramural Hematoma (IMH) in landing zones

9. Prosthetic heart valve in the aortic position that precludes safe delivery of theASG device

10. Aortic insufficiency grade 3 or greater

11. Previous endovascular repair with a non-Gore device that would interfere with orresult in contact with planned repair

12. Concomitant vascular disease requiring treatment that is not planned for indexendovascular procedure

13. Any stroke or myocardial infarction within 6 weeks prior to treatment

14. Presence of protruding and/or irregular thrombus and/or atheroma in the ascendingaorta or aortic arch or any other factors that could increase the risk of strokebased on imaging review

15. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-DanlosSyndrome, EDS)

16. Participation in investigational drug or medical device study within one year ofenrollment unless approved by the sponsor

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

18. Pregnant at time of procedure

19. Active infected aorta, mycotic aneurysm

20. Active systemic infection (e.g., infection requiring treatment with parenteralanti-infective medication)

21. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (mL/min/1.73 m2) or currently requiring dialysis

22. Life expectancy <12 months

23. Known sensitivities or allergies to the device materials

24. Known hypersensitivity or contraindication to anticoagulants or contrast media,which is not amenable to pre-treatment

25. Body habitus or other medical condition which prevents adequate fluoroscopic and CTvisualization of the aorta

Inclusion Criteria: ASG + TBE Device Arm

The patient is/has:

1. Ascending and/or Arch Aortic pathologies warranting surgical repair compatible withthe treatment requirements of the ASG device and meeting any of the followingcriteria: Aneurysms

2. Fusiform aneurysm (≥55 mm or documented growth rate >0.5cm/year)

3. Saccular aneurysm (no diameter criteria)

4. Pseudoaneurysms (>30 days post-surgery, no diameter criteria) Non-aneurysms

5. Penetrating Aortic Ulcers (no diameter criteria)

6. Pseudoaneurysms, following open surgical repair of a Type A dissection (>30days post-surgery, no diameter criteria)

7. Chronic de novo (>90 days) Type A aortic dissection requiring treatment

• Chronic de novo aortic dissection with primary entry tear in the ascendingaorta or arch
• Chronic de novo aortic dissection with primary entry tear in thedescending thoracic aorta with retrograde involvement of the aortic archand/or ascending aorta

7. Residual aortic dissection following surgical repair of Type A aorticdissection requiring treatment (>30 days post-surgery)

8. Anatomic compatibility with ASG device used in combination with the TBE Device basedon Gore Imaging Sciences review. Proximal Aortic Landing Zone:

9. Landing zone is native aorta or surgical graft

10. Lesion location is ≥2cm distal to the most distal coronary artery ostia

11. Proximal landing zone must be ≥2cm in the ascending aorta.

12. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed

13. Landing zone diameter between 27mm - 48mm

14. Acceptable proximal landing zone outer curvature length for the required device Branch Vessel Landing Zone:

15. Length of ≥2.5 cm proximal to first major branch vessel

16. Target branch vessel inner diameters of 11-18 mm

17. Target branch vessel landing zone must be in native vessel that cannot beheavily calcified, or heavily thrombosed Distal Aortic Landing Zone:

18. Outer curvature must be ≥2 cm proximal to the celiac artery

19. Aortic inner diameters between 16-42 mm

20. Landing zone in native aorta or previously implanted GORE® TAG® ConformableThoracic Stent Graft (CTAG Device)

21. Considered high-risk for open surgical repair by meeting any of the followingcriteria:

22. ≥75 years of age

23. Previous median sternotomy

24. Documented identification of other subject-specific risk factors (e.g., medicalhistory, active medical diagnosis) by a study investigator and an experiencedopen ascending and/or aortic arch surgeon (e.g., cardiothoracic surgeon).

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

26. Adequate vascular access via transfemoral or retroperitoneal approach

27. Informed Consent Form (ICF) signed by the subject or legally authorizedrepresentative

28. Agrees to comply with protocol requirements, including imaging and 5-year follow-up

Exclusion Criteria: ASG + TBE Device Arm

The patient is/has:

1. Acute and subacute de novo Type A dissection (defined as <90 days)

2. Requires immediate treatment

3. Dissected great vessels requiring treatment

4. Anticipated need for coronary or aortic valve intervention within one year posttreatment

5. Any aortic valve repair or replacement including transcatheter aortic valvereplacement (TAVR) or coronary artery intervention within 30 days prior to treatment

6. Complex percutaneous coronary intervention (PCI) or treatment for acute coronarysyndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior totreatment.

7. Open chest surgical repair within 30 days prior to treatment

8. Presence of Intramural Hematoma (IMH) in landing zones

9. Prosthetic heart valve in the aortic position that precludes safe delivery of theASG device

10. Aortic insufficiency grade 3 or greater.

11. Previous endovascular repair with a non-Gore device that would interfere with orresult in contact with planned repair

12. Concomitant vascular disease requiring treatment that is not planned for indexendovascular procedure

13. Any stroke or myocardial infarction within 6 weeks prior to treatment

14. Presence of protruding and/or irregular thrombus and/or atheroma in the ascendingaorta or aortic arch or any other factors that could increase the risk of strokebased on imaging review

15. Known degenerative connective tissue disease (e.g., Marfan Syndrome or Ehlers-DanlosSyndrome, EDS)

16. Participation in investigational drug or medical device study within one year ofenrollment unless approved by the sponsor

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

18. Pregnant at time of procedure

19. Active infected aorta, mycotic aneurysm

20. Active systemic infection (e.g., infection requiring treatment with parenteralanti-infective medication)

21. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (mL/min/1.73 m2) or currently requiring dialysis

22. Life expectancy <12 months

23. Known sensitivities or allergies to the device materials

24. Known hypersensitivity or contraindication to anticoagulants or contrast media,which is not amenable to pre-treatment

25. Body habitus or other medical condition which prevents adequate fluoroscopic and CTvisualization of the aorta

26. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or knownhypersensitivity to heparin or a history of a hypercoagulability disorder and/orstate

Inclusion Criteria: Surgical Follow-up Cohort

Subjects who meet the following criteria will be followed:

1. The aortic lesion involves the ascending aorta and/or aortic arch

2. The subject is determined to be high-risk for open surgical repair per the protocolrequirements

3. The subject is at least 18 years of age

4. The subject is willing to comply with the protocol requirements

5. Open surgery to repair the aortic lesion the patient was screened for is intended tobe performed at the investigational site responsible for initiating the screeningprocess for the study