TBE Zone 0/1 PMS in Japan

Thoracic Aortic Aneurysm: 50 patients (including at least 5 surgically repaired patients who have the proximal landing zone that is a surgical graft)

Before 5 surgically repaired patients are enrolled if the other 45 patients are confirmed to be enrolled, enrollment of the other patients will be considered complete at that point, and only surgically repaired patients will continue to be enrolled.

• Complicated chronic Stanford type B aortic dissection (including dissecting aneurysm): at least 10 patients, and enrollment will be considered complete when the enrollment of 15 patients is confirmed.
• Complicated Stanford type A (after surgical repair) aortic dissection: at least 10 patients, and enrollment will be considered complete when the enrollment of 15 patients is confirmed.

If, during the enrollment period for the dissection and traumatic transection cohort, an attempt is made to place TBE in patients with complicated acute Stanford type B aortic dissection or in patients with traumatic thoracic aortic transection, those patients will also be enrolled in the dissection and traumatic transection cohort.

All of the following must be met.

• Successful access and delivery
• Patency of devices
• The absence of unanticipated additional procedure related to the device, the TBE implant procedure, or withdrawal of the delivery system

Lesion-related Mortality that meet any of the following criteria:

• All deaths within 30 days after the revascularization procedure or the TBE implant procedure during the initial hospitalization or secondary procedures resulting from the treated lesion or endovascular treatment (e.g., procedures for retrograde dissection, loss of patency, loss of device integrity, endoleak, migration, aortic dilation, aneurysm rupture)
• All deaths related to the treated lesion or device (e.g., aneurysm rupture, retrograde dissection resulting in fatal cardiac tamponade) Not applicable if there is evidence to support no relationship to the lesion.

Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that:

Persists for > 24 hours or until death

Additional unanticipated surgical procedure or endovascular procedure related to TBE, TBE implant procedure, or revascularization procedure for TBE implant after the revascularization procedure or TBE implant procedure.

Anticipated or unanticipated status will be determined at the discretion of the investigator.

Surgical procedures include conversion to thoracotomy. Endovascular procedures include stent graft implants for endoleaks, aortic enlargement and loss of patency, and procedures on the branch to improve or restore patency.

Events will not include access site(s) complications, interventions to address issues related to non-treated area of the index lesion, such as bare stent implant to address bowel ischemia associated with aortic dissection.

Serious adverse events reported or confirmed by imaging by the sites.

The definitions of each type of endoleaks are as follows:

• Type I endoleak is defined as a sealing failure at one of the attachment sites of the graft to the vessel wall. Arterial flow therefore leaks alongside the graft and into the perigraft space.
• Type Ia: Proximal leak
• Type Ib: Distal leak
• Type Ic: Inadequate seal at distal landing zone for side branch component
• Type II endoleak is defined as retrograde flow from branch arteries arising from the treated segment of the aorta.
• Type III endoleak
• Type IIIA endoleak : Attachment of aortic components (aortic-aortic).
• Type IIIB endoleak : Fabric tear or disruption.
• Type IIIC endoleak : Attachment of aortic component-side-branch or side-branch-side-branch
• Type IV endoleak is defined as flow through porous fabric.
• Indeterminate : Endoleak detected with unknown source.

Defined as any of the following:

• Wire fractures identified in the sealing row stents of the aortic component (AC), branch component (SB) or aortic extender (AE).
• Stent kinking: Narrowing of the stent graft associated with demonstrable angulation in any of the stent components, with demonstrable flow
• Disruption / tears in the graft component of the stent graft
• Transient (compression) or permanent stent-graft collapse (invagination) following complete device deployment, resulting in an overall reduction in the aortic or branch vessel luminal diameter.
• If the device loses function due to other malformations

The thrombosis state of the false lumen at the treated and untreated segments at the TBE implant procedure is confirmed using the following three stages.

• Patent is defined as flow present throughout the aortic false lumen in the absence of evidence of thrombus.
• Partially thrombosed false lumen is defined as clot within the aortic false lumen that has a residual patent flow channel.
• Thrombosed false lumen is defined as complete thrombosis of the aortic false lumen.