Early safety study of a branched stent graft for aortic arch disease

Who can take part

• The subject is / has:
• Thoracic pathologies with involvement of the arch branch vessels, that are compatible with the treatment requirements of the MBA device, and meeting any of the following criteria:; Aneurysm and Isolated Lesions: i. Fusiform aneurysm (≥ 55 mm or documented growth rate > 0.5 cm/year). ii. Saccular aneurysm (no diameter criteria). iii. Pseudoaneurysms (> 30 days post-surgery, no diameter criteria). iv. Penetrating Aortic Ulcers (PAUs) without intramural hematoma (IMH) (no diameter criteria); Aortic dissection: i. Uncomplicated and high-risk chronic de novo (> 90 days) Type B aortic dissection with primary entry tear in the arch or descending thoracic aorta; Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (> 30 days post-treatment); Proximal extension of prior endovascular repair (> 30 days post-treatment and > 90 days post-dissection) of a Type B dissection requiring treatment; Pseudoaneurysms, following open surgical repair of a Type A dissection (> 30 days post-surgery, no diameter criteria)
• Anatomic compatibility with MBA device and other devices required for proximal or distal extensions based on Gore's review; Adequate vascular access via transfemoral or retroperitoneal approach; Appropriate vascular access to allow for through-wire access to the brachiocephalic artery, LCCA, and LSA; Proximal Aortic Landing Zone:; Landing zone is native aorta, surgical graft, or previously implanted GORE thoracic stent graft
• Landing zone diameter between 27 mm - 48 mm. iii. Acceptable ascending aorta outer curvature length for the required MBA device
• Proximal segment length (length from distal edge of brachiocephalic artery to distal edge of the most distal coronary artery) must be ≥ 2 cm longer than the "AC Proximal End to BCA Portal Length" for the selected Aortic Component or ≥ 3 cm if the landing zone is > 42 mm
• For patients with patent bypass graft from the ascending aorta, proximal extent of landing zone must be ≥ 1 cm distal to the bypass graft
• Lesion location is ≥ 2 cm distal to the most distal coronary artery ostium. v. For patients with an existing transcatheter aortic valve replacement (TAVR) there must be a sufficient proximal landing zone to avoid interference with the required MBA device (including any proximal extensions with the ASG device)
• Proximal landing zone must be ≥ 2 cm in the ascending aorta
• For patients with prior replacement of the ascending aorta and / or aortic arch by surgical graft, there must be ≥ 2 cm overlap of MBA device and previously implanted graft
• For patients with a de novo aortic dissection, the primary entry tear must be located ≥ 2 cm distal to the proximal extent of the MBA device (including any proximal extensions) and the proximal edge of the stent graft must land in non-dissected aorta; Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed; Branch Vessel Landing Zone: i. Length of ≥ 2.5 cm proximal to first major branch vessel. ii. Target branch vessel inner diameter of 11-18 mm for the 12 mm portal, and 6-15 mm for the 8 mm portal; Target branch vessel landing zone must be in native aorta that cannot be heavily calcified, or heavily thrombosed; All three arch target vessels must have appropriate anatomy for cannulation (including through-wire access) and treatment with MBA branch components; Distal Aortic Landing Zone (aneurysms and isolated lesions only): i. Outer curvature length must be ≥ 2 cm proximal to the celiac artery. ii. Aortic inner diameters between 16-42 mm. iii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed; Landing zone in native aorta, surgical graft, or previously implanted GORE thoracic stent graft
• Age ≥ 18 years at time of informed consent signature
• Informed Consent Form (ICF) signed by the subject or legally authorized representative (LAR), according to local regulation
• Agrees to comply with protocol requirements, including imaging and five year (60 month) follow-up
• Considered high-risk for open surgical repair by meeting one or more 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)
• Considered high-risk for surgical debranching by meeting one or more of the following criteria:; Prior neck surgery or radiation; Neck anatomy / body habitus impeding carotid access or safe bypass tunneling; Dysphagia; Elevated risk for post-operative infection (e.g., malnutrition, uncontrolled diabetes (hemoglobin A1c > 9%), current treatment with immunosuppressant therapy or chemotherapy); Reduced pulmonary function (e.g., severe chronic obstructive pulmonary disease (COPD), current or anticipated tracheostomy); Clinical Frailty Scale score 6-7; Documented identification of other subject-specific risk factors which would pose high risk for surgical debranching (e.g., medical history, active medical diagnosis) by a study investigator

Who cannot take part

• 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) within 30 days prior to treatment
• Open chest surgical repair within 30 days prior to treatment
• Any open or interventional repair of either carotid artery within 30 days prior to treatment
• Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair
• Concomitant vascular disease, including disease associated with the great and upper extremity vessels, requiring treatment that is not planned for index endovascular procedure
• Any stroke or MI within 90 days prior to treatment
• Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor
• Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication)
• 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
• Prosthetic heart valve in the aortic position that precludes safe delivery of any study device
• Aortic insufficiency (AI) grade 3 or greater
• Presence of protruding and / or irregular thrombus and / or atheroma in the ascending aorta or aortic arch or any other factor that could increase the risk of stroke based on Gore's review
• Any chronic condition that is not well controlled and that is known to increase stroke risk
• Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome (EDS))
• Known medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up, such as a history of drug abuse within one year of treatment
• Active infected aorta, mycotic aneurysm
• 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
• Severe Congestive Heart Failure (CHF) (New York Heart Association (NYHA) functional class IV)
• Acute Coronary Syndrome (ACS) including unstable angina
• Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) < 30 (mL/min/1.73 m2) or currently requiring dialysis
• The subject is / has:
• De novo Type A dissection
• Requires immediate treatment
• Arch vessels with dissection extending into the intended landing zones
• Anticipated need for coronary or aortic valve intervention within one year post-treatment
• Presence of Intramural Hematoma (IMH) in landing zones
• Pregnant at time of procedure or planning to become pregnant within the first 12-months of participation in the study
• Life expectancy <12 months