Evaluation of the GORE® Ascending Stent Graft

Inclusion Criteria

• •The patient is/has:
• •1. Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm
• •1. Fusiform aneurysm (≥50mm or documented growth rate \>0.5cm/year)
• •2. Saccular aneurysm (no diameter criteria)
• •3. Pseudoaneurysms (\>30 days post-surgery, no diameter criteria) Non-aneurysm
• •4. Penetrating Aortic Ulcers (PAUs) (no diameter criteria)
• •5. Pseudoaneurysms, following open surgical repair of a Type A dissection (\>30 days post-surgery, no diameter criteria)
• •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 (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).
• •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
• •The patient is/has:
• •1. 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
• •1. Fusiform aneurysm (≥55 mm or documented growth rate \>0.5cm/year)
• •2. Saccular aneurysm (no diameter criteria)
• •3. Pseudoaneurysms (\>30 days post-surgery, no diameter criteria) Non-aneurysms
• •4. Penetrating Aortic Ulcers (no diameter criteria)
• •5. Pseudoaneurysms, following open surgical repair of a Type A dissection (\>30 days post-surgery, no diameter criteria)
• •6. 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
• •7. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (\>30 days post-surgery)
• •2. Anatomic compatibility with ASG device used in combination with the TBE Device based on Gore Imaging Sciences review.
• •Proximal Aortic Landing Zone:
• •1. Landing zone is native aorta or surgical graft
• •2. Lesion location is ≥2cm distal to the most distal coronary artery ostia
• •3. Proximal landing zone must be ≥2cm in the ascending aorta.
• •4. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
• •5. Landing zone diameter between 27mm - 48mm
• •6. Acceptable proximal landing zone outer curvature length for the required device
• •Branch Vessel Landing Zone:
• •1. Length of ≥2.5 cm proximal to first major branch vessel
• •2. Target branch vessel inner diameters of 11-18 mm
• •3. Target branch vessel landing zone must be in native vessel that cannot be heavily calcified, or heavily thrombosed
• •Distal Aortic Landing Zone:
• •1. Outer curvature must be ≥2 cm proximal to the celiac artery
• •2. Aortic inner diameters between 16-42 mm
• •3. Landing zone in native aorta or previously implanted GORE® TAG® Conformable Thoracic Stent Graft (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 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).
• •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
• •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 protocol requirements
• •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 to be performed at the investigational site responsible for initiating the screening process for the study