Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms. Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.
∙ The patient must have one of the following:
• Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or
• Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
• Penetrating ulcers: ≥20mm in depth or
• Chronic type B aortic dissections: ≥50mm total aortic diameter or
• Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.
∙ Additional criteria for LP material
∙ • Iliofemoral access vessels \<8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator
∙ The subject must have one of the following:
• Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or \> 50 mm with a history of growth ≥5 mm in the last 6 months, or
• Penetrating ulcers: ≥20 mm in depth, or
• Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.
‣ Age \>85 years old.
⁃ Prior median sternotomy (for any reason).
⁃ Prior open or endovascular thoracic aortic repair.
⁃ Severe aortic calcification.
⁃ Severe occlusive disease of one or more arch vessels.
⁃ Moderate-severe COPD (FEV1 \<80% predicted).
⁃ Severe CKD (Stage 3 or greater, eGFR \<60 mL/min).
⁃ LV dysfunction.
⁃ Chronic steroid or immunosuppressive use.
‣ History of increased risk of bleeding.
‣ Neurocognitive deficits that may significantly impact postoperative rehabilitation.
‣ Musculoskeletal conditions that may significantly impact postoperative rehabilitation.