Terumo Aortic Global Endovascular Registry

Technical Success

defined as: Successful delivery of the device through the vasculature (i.e. ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery). Deployment of the endovascular stent-graft in the planned location with coverage of the target lesion (or entry tear in the case of dissection);Absence of unplanned coverage or aortic branch vessels; Patency of the endovascular stent-graft, absence of device deformations (e.g. kinks, stent eversion, maldeployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stentgraft, and;Successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal). Absence of Type Ia, Type Ib, Type IIIa and IIIb endoleak that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography \[MRA\], or duplex ultrasound).

Time frame: Day 0

Composite Clinical Success

defined as the absence of: Target lesion related mortality Type Ia, Ib, IIIa and IIIb endoleak Graft infection Stent patency \<50% Target lesion aortic rupture Conversion to open repair Arrest of the original pathological process (e.g., total aortic diameter expansion \>5 mm in the aorta that has a study endograft, embolization from penetrating ulcer, extension of dissection, false lumen perfusion) or a new aortic pathology as a result of the intervention (e.g., pseudoaneurysm, dissection, intramural hematoma, unintentional adverse dissection septum rupture, stent-graft induced aortic wall injury, new aortobronchial/tracheal or aortoenteric fistula formation)

Time frame: 1 year

Additional Endpoints

All-cause mortality Safety (MAEs, all related adverse events) Target lesion reintervention, all secondary interventions Device performance based on imaging assessments of all morphological variables (aortic remodeling, all endoleaks, any loss of patency, stent-graft migration, device integrity, etc.)