Evaluation of the GORE® Ascending Stent Graft

Launched by W.L.GORE & ASSOCIATES · Mar 23, 2023

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Eligibility criteria

• • Inclusion Criteria: ASG Device Alone Arm
• 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
• • 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 transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
• • 6. Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (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 or result in contact with planned repair
• • 12. Concomitant vascular disease requiring treatment that is not planned for index endovascular 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 ascending aorta or aortic arch or any other factors that could increase the risk of stroke based on imaging review
• • 15. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome, EDS)
• • 16. Participation in investigational drug or medical device study within one year of enrollment 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 parenteral anti-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 CT visualization of the aorta
• • Inclusion Criteria: ASG + TBE Device Arm
• 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
• • 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 post treatment
• • 5. Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
• • 6. Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (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 or result in contact with planned repair
• • 12. Concomitant vascular disease requiring treatment that is not planned for index endovascular 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 ascending aorta or aortic arch or any other factors that could increase the risk of stroke based on imaging review
• • 15. Known degenerative connective tissue disease (e.g., Marfan Syndrome or Ehlers-Danlos Syndrome, EDS)
• • 16. Participation in investigational drug or medical device study within one year of enrollment 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 parenteral anti-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 CT visualization of the aorta
• • 26. 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:
• • 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