Evaluation of the GORE® Ascending Stent Graft

Inclusion criteria

ASG Device Alone Arm

The patient is/has:

• Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm

• Fusiform aneurysm (≥50mm or documented growth rate >0.5cm/year)
• Saccular aneurysm (no diameter criteria)
• Pseudoaneurysms (>30 days post-surgery, no diameter criteria) Non-aneurysm
• Penetrating Aortic Ulcers (PAUs) (no diameter criteria)
• Pseudoaneurysms, following open surgical repair of a Type A dissection (>30 days post-surgery, no diameter criteria)
• Anatomic compatibility with ASG device based on Gore Imaging Sciences review.

• Treatment must be limited to the ascending aorta
• Lesion location is ≥2cm distal to the most distal coronary artery ostia
• Distal extent of the lesion is located ≥2cm proximal to the origin of the Brachiocephalic Artery (BCA)
• Proximal and distal landing zones must be ≥2cm in length
• Landing zones cannot be heavily calcified, or heavily thrombosed
• Landing zone diameter between 27mm - 48mm
• 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.
• Considered high-risk for open surgical repair by meeting any of the following criteria:

• ≥75 years of age
• Previous median sternotomy
• Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and/or aortic arch surgeon (e.g., cardiothoracic surgeon).
• Age ≥18 years at time of informed consent signature
• Adequate vascular access via transfemoral or retroperitoneal approach
• Informed Consent Form (ICF) signed by the subject or legally authorized representative
• Agrees to comply with protocol requirements, including imaging and 5-year follow-up

Exclusion criteria

ASG Device Alone Arm

The patient is/has:

• De novo Type A dissection
• Requires immediate treatment
• Dissected great vessels requiring treatment
• Anticipated need for coronary or aortic valve intervention within one year post treatment
• Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
• Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment
• Open chest surgical repair within 30 days prior to treatment
• Presence of Intramural Hematoma (IMH) in landing zones
• Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device
• Aortic insufficiency grade 3 or greater
• Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair
• Concomitant vascular disease requiring treatment that is not planned for index endovascular procedure
• Any stroke or myocardial infarction within 6 weeks prior to treatment
• Presence of protruding and/or irregular thrombus and/or atheroma in the ascending aorta or aortic arch or any other factors that could increase the risk of stroke based on imaging review
• Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome, EDS)
• Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor
• Known history of drug abuse within one year of treatment
• Pregnant at time of procedure
• Active infected aorta, mycotic aneurysm
• Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication)
• Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (mL/min/1.73 m2) or currently requiring dialysis
• Life expectancy <12 months
• Known sensitivities or allergies to the device materials
• Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
• Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta

Inclusion criteria

ASG + TBE Device Arm

The patient is/has:

• Ascending and/or Arch Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device and meeting any of the following criteria: Aneurysms

• Fusiform aneurysm (≥55 mm or documented growth rate >0.5cm/year)
• Saccular aneurysm (no diameter criteria)
• Pseudoaneurysms (>30 days post-surgery, no diameter criteria) Non-aneurysms
• Penetrating Aortic Ulcers (no diameter criteria)
• Pseudoaneurysms, following open surgical repair of a Type A dissection (>30 days post-surgery, no diameter criteria)
• Chronic de novo (>90 days) Type A aortic dissection requiring treatment

• Chronic de novo aortic dissection with primary entry tear in the ascending aorta or arch
• Chronic de novo aortic dissection with primary entry tear in the descending thoracic aorta with retrograde involvement of the aortic arch and/or ascending aorta
• Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (>30 days post-surgery)
• Anatomic compatibility with ASG device used in combination with the TBE Device based on Gore Imaging Sciences review.

Proximal Aortic Landing Zone:

• Landing zone is native aorta or surgical graft
• Lesion location is ≥2cm distal to the most distal coronary artery ostia
• Proximal landing zone must be ≥2cm in the ascending aorta.
• Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
• Landing zone diameter between 27mm - 48mm
• Acceptable proximal landing zone outer curvature length for the required device

Branch Vessel Landing Zone:

• Length of ≥2.5 cm proximal to first major branch vessel
• Target branch vessel inner diameters of 11-18 mm
• Target branch vessel landing zone must be in native vessel that cannot be heavily calcified, or heavily thrombosed

Distal Aortic Landing Zone:

• Outer curvature must be ≥2 cm proximal to the celiac artery
• Aortic inner diameters between 16-42 mm
• Landing zone in native aorta or previously implanted GORE® TAG® Conformable Thoracic Stent Graft (CTAG Device)
• Considered high-risk for open surgical repair by meeting any of the following criteria:

• ≥75 years of age
• Previous median sternotomy
• Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and/or aortic arch surgeon (e.g., cardiothoracic surgeon).
• Age ≥18 years at time of informed consent signature
• Adequate vascular access via transfemoral or retroperitoneal approach
• Informed Consent Form (ICF) signed by the subject or legally authorized representative
• Agrees to comply with protocol requirements, including imaging and 5-year follow-up

Exclusion criteria

ASG + TBE Device Arm

The patient is/has:

• Acute and subacute de novo Type A dissection (defined as <90 days)
• Requires immediate treatment
• Dissected great vessels requiring treatment
• Anticipated need for coronary or aortic valve intervention within one year post treatment
• Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
• Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment.
• Open chest surgical repair within 30 days prior to treatment
• Presence of Intramural Hematoma (IMH) in landing zones
• Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device
• Aortic insufficiency grade 3 or greater.
• Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair
• Concomitant vascular disease requiring treatment that is not planned for index endovascular procedure
• Any stroke or myocardial infarction within 6 weeks prior to treatment
• Presence of protruding and/or irregular thrombus and/or atheroma in the ascending aorta or aortic arch or any other factors that could increase the risk of stroke based on imaging review
• Known degenerative connective tissue disease (e.g., Marfan Syndrome or Ehlers-Danlos Syndrome, EDS)
• Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor
• Known history of drug abuse within one year of treatment
• Pregnant at time of procedure
• Active infected aorta, mycotic aneurysm
• Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication)
• Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (mL/min/1.73 m2) or currently requiring dialysis
• Life expectancy <12 months
• Known sensitivities or allergies to the device materials
• Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
• Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and/or state

Inclusion criteria

Surgical Follow-up Cohort

Subjects who meet the following criteria will be followed:

• The aortic lesion involves the ascending aorta and/or aortic arch
• The subject is determined to be high-risk for open surgical repair per the protocol requirements
• The subject is at least 18 years of age
• The subject is willing to comply with the protocol requirements
• Open surgery to repair the aortic lesion the patient was screened for is intended to be performed at the investigational site responsible for initiating the screening process for the study