Clinical Trials

2. Anatomic compatibility with ASG device based on Gore Imaging Sciences review.
   1. Treatment must be limited to the ascending aorta
   2. Lesion location is ≥2cm distal to the most distal coronary artery ostia
   3. Distal extent of the lesion is located ≥2cm proximal to the origin of the Brachiocephalic 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 arch by an endovascular or surgical graft, there must be at least ≥2 cm overlap of ASG device and previously implanted graft.
3. Considered high-risk for open surgical repair by meeting any of the following criteria:
   1. ≥75 years of age
   2. Previous median sternotomy
   3. Documented identification of other subject-specific risk factors by a study investigator and an experienced open ascending and/or aortic arch surgeon
4. Age ≥18 years at time of informed consent signature
5. Adequate vascular access via transfemoral or retroperitoneal approach
6. Informed Consent Form (ICF) signed by the subject or legally authorized representative
7. 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 post treatment
5. Any aortic valve repair or replacement including TAVR or coronary artery intervention within 30 days prior to treatment
6. Complex PCI or treatment for acute coronary syndrome requiring DAPT within 30 days prior to treatment
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 the ASG device
10. Aortic insufficiency grade 3 or greater
11. Previous endovascular repair with a non-Gore device that would interfere with planned repair
12. Concomitant vascular disease requiring treatment not planned for index procedure
13. Any stroke or myocardial infarction within 6 weeks prior to treatment
14. Presence of protruding or irregular thrombus or atheroma in the ascending aorta or arch
15. Known degenerative connective tissue disease
16. Participation in investigational drug or device study within one year unless approved
17. Known history of drug abuse within one year
18. Pregnant at time of procedure
19. Active infected aorta or mycotic aneurysm
20. Active systemic infection
21. Renal failure with eGFR <30 or requiring dialysis
22. Life expectancy <12 months
23. Known sensitivities or allergies to device materials
24. Known hypersensitivity or contraindication to anticoagulants or contrast media
25. Body habitus or condition preventing adequate fluoroscopic or CT visualization

Inclusion Criteria: ASG + TBE Device Arm

The patient is/has:

1. Ascending and/or Arch Aortic pathologies warranting surgical repair compatible with ASG device requirements and meeting any of the following criteria: Aneurysms
   1. Fusiform aneurysm (≥55 mm or growth rate >0.5cm/year)
   2. Saccular aneurysm (no diameter criteria)
   3. Pseudoaneurysms (>30 days post-surgery, no diameter criteria)
   4. Penetrating Aortic Ulcers
   5. Pseudoaneurysms following open repair of Type A dissection (>30 days post-surgery)
   6. Chronic de novo (>90 days) Type A aortic dissection requiring treatment
      • Chronic de novo dissection with primary entry tear in ascending aorta or arch
      • Chronic de novo dissection with primary entry tear in descending thoracic aorta with retrograde involvement
   7. Residual aortic dissection following surgical repair (>30 days post-surgery)
2. Anatomic compatibility with ASG + TBE device based on Gore Imaging Sciences review.

   Proximal Aortic Landing Zone:

   1. Landing zone is native aorta or surgical graft
   2. Lesion location ≥2cm distal to most distal coronary artery ostia
   3. Proximal landing zone ≥2cm in ascending aorta
   4. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
   5. Landing zone diameter 27mm - 48mm
   6. Acceptable proximal landing zone outer curvature length

   Branch Vessel Landing Zone:

   1. Length ≥2.5 cm proximal to first major branch vessel
   2. Target branch vessel inner diameters 11-18 mm
   3. Landing zone must be native vessel not heavily calcified or thrombosed

   Distal Aortic Landing Zone:

   1. Outer curvature ≥2 cm proximal to celiac artery
   2. Aortic inner diameters 16-42 mm
   3. Landing zone in native aorta or prior GORE CTAG device
3. Considered high-risk for open surgical repair by meeting any of the following criteria:
   1. ≥75 years of age
   2. Previous median sternotomy
   3. Documented subject-specific risk factors identified by investigator and surgeon
4. Age ≥18 years
5. Adequate vascular access
6. ICF signed
7. Agrees to comply with protocol and follow-up

Exclusion Criteria: ASG + TBE Device Arm

The patient is/has:

1. Acute or subacute de novo Type A dissection (<90 days)
2. Requires immediate treatment
3. Dissected great vessels requiring treatment
4. Anticipated need for coronary or aortic valve intervention within one year
5. Aortic valve repair or replacement including TAVR within 30 days
6. Complex PCI or ACS requiring DAPT within 30 days
7. Open chest surgical repair within 30 days
8. Presence of IMH in landing zones
9. Prosthetic aortic valve preventing safe delivery
10. Aortic insufficiency grade 3 or greater
11. Previous endovascular repair with non-Gore device interfering with planned repair
12. Concomitant vascular disease requiring treatment not planned for index procedure
13. Stroke or MI within 6 weeks
14. Protruding or irregular thrombus or atheroma increasing stroke risk
15. Known connective tissue disease
16. Participation in investigational study within one year unless approved
17. History of drug abuse within one year
18. Pregnant at time of procedure
19. Active infected aorta or mycotic aneurysm
20. Active systemic infection
21. Renal failure with eGFR <30 or requiring dialysis
22. Life expectancy <12 months
23. Known sensitivities to device materials
24. Hypersensitivity or contraindication to anticoagulants or contrast media
25. Body habitus preventing adequate imaging
26. Previous HIT-2 or hypersensitivity to heparin

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
3. The subject is at least 18 years of age
4. The subject is willing to comply with protocol requirements
5. Open surgery for the screened lesion is intended to be performed at the investigational site