Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch Pathologies Using Cook Custom Aortic Endografts, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endograft
This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels. The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.
• Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:
‣ Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.
• Diameter \> 5.5 cm if asymptomatic, or 5.0 cm with enlargement of \> 0.5 cm in 6 months.
∙ History of growth \> 0.5 cm per year
∙ Any size if ruptured or symptomatic
⁃ Penetrating aortic ulcer (PAU)
• \> 2.0 cm in depth
∙ Any size if contained ruptured or symptomatic
⁃ Subacute (\>14 days) or chronic (\>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:
• Total aortic diameter \> 5.5 cm if asymptomatic
∙ Total aortic diameter \> 4.5 cm if symptomatic
∙ Total aortic diameter \> 5.0 cm and history of growth \> 0.5 cm in 6 months
• Aortic Arch pathology:
‣ Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aortic dissection, Retrograde type A thoracic aortic dissection between the Sinus of Valsalva and the innominate artery orifice (without involvement of the Aortic Valve), or Ascending penetrating aortic ulcer with and without intramural hematoma
⁃ Suitable iliac artery and brachial artery access
⁃ Absence of severe landing zone (\> 90 degree) angulation that would preclude necessary device delivery/seal/fixation.
⁃ Suitable iliac artery access to accommodate device delivery system.
⁃ Target arteries for arch branches:
• \< 24 mm diameter
∙ Adequate landing zone length to obtain proximal and distal seal.
∙ Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity/thrombus/calcification.
• Aortic Arch Aneurysm
‣ Proximal aortic fixation zone:
• Native aorta or surgical graft
∙ Diameter: 20 - 42 mm
⁃ Proximal neck length \> 20 mm
⁃ Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.
⁃ Distal aortic fixation zone:
• Native aorta or surgical graft
∙ Diameter: 20 - 44 mm
⁃ Distal neck length \> 20 mm. However, if dissection, distal graft may land in dissected aorta.
⁃ Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery
• Native vessel or surgical graft
∙ Diameter: 8 - 22 mm
∙ Length of sealing zone \> 10 mm
∙ Acceptable tortuosity B. Left (or right) common carotid artery
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• Native vessel or surgical graft
∙ Diameter 5 - 20 mm
∙ Length of sealing zone \> 10 mm C. Left (or right) subclavian artery
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• Native vessel or surgical graft
∙ Diameter 5 - 20 mm
∙ Length of sealing zone \> 10 mm
• Aortic Dissection
‣ Access into the true lumen from the groin and at least one supra-aortic trunk vessel.
⁃ Seal zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen.
⁃ Seal zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen or surgically created.
⁃ True lumen size large enough to deploy the device and still gain access into the target branch.