Endovascular treatment of ascending aortic lesions has been reported, but no Food and Drug Administration (FDA)-approved studies have been conducted to define the use of endografts in this particular location or analyze the critical factors involved. Patients were consented for entry into an FDA-approved physician-sponsored investigational device exemption (PS-IDE) study to investigate the outcome of patients with ascending aortic pathologies who were suitable for endovascular repair with a Valiant Captivia thoracic stent graft specifically designed for deployment in the ascending aorta. Anatomic criteria required proximal and distal landing zones to be at least 1 cm in length, a diameter between 28 and 44 mm, and be classified as high-risk with an American Society of Anesthesiologists grade 4. All patients had sequential gated-cardiac computed tomography (CT) scans, with data being entered into the Vascular Quality Initiative Complex TEVAR software. All procedures were performed hybrid room, with the capability to convert to an open repair to ensure maximal patient protection. The first five patients constituted the feasibility study, with continued enrollment based on initial results and submission of an annual report to the FDA. Eighteen patients were screened, with six patients entered into the PS-IDE. There were no periprocedural or 30-day mortalities, and one late death. All patients had sequential CTs and cardiac echocardiograms with no evidence of migration, only one endoleak, and regression of the aortic lesions in the treated aortic segment. One patient withdrew from the study after 6 months. Preliminary evaluation of endovascular treatment for ascending aortic pathologies demonstrates uniform accuracy of deployment and secure fixation up to 1 year. There is positive remodeling of the excluded aortic segments as has been observed in the descending aorta. Due to the severe aortic/cardiac angle encountered in some patients, the FDA has granted approval to use the transapical access for device deployment.TableNo.Age (year)GenderDiagnosisDevices (No.)Complication177MalePenetrating ulcer1Wire perforation left ventricle283FemalePseudoaneurysm1Lacunar infarct, persistent endoleak387FemalePenetrating ulcer1Rupture 2nd PAU open repair485MalePseudoaneurysm2Aortic valve leaflet entrapment566MalePseudoaneurysm1None653MaleDissection and aneurysm1None Open table in a new tab