The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.

TBE Zone 2 PMS in Japan

Aneurysm Thoracic

Dissection of Aorta, Thoracic

Trauma

Gore® TAG® Thoracic Aortic Branch Stent Graft System

GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance in Japan

All of the following must be met.

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

Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.

Lesion-related Mortality definition

Deaths that meet any of the following criteria:

* All deaths within 30 days after the initial 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

Paraplegia secondary to spinal cord ischemia reported as a serious adverse event from sites.

Paraparesis secondary to spinal cord ischemia reported as a serious adverse event from sites.

Renal failure reported as a serious adverse event by sites and confirmed to require dialysis.

Additional unanticipated surgical procedure or endovascular procedure after the initial procedure.

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

Surgical procedures include conversion to thoracotomy, and endovascular procedures includes the placement of devices other than TBE.

Endovascular procedures at the access site, lumbar drains for spinal cord ischemia, and procedures to address problems other than the treatment site (such as bare stent placement for intestinal ischemia due to dissection) do not apply.

Ischemia reported by sites as a serious adverse event determined to be related to the device.

Device-related ischemic adverse events reported by sites as serious adverse events that required bypass surgery, surgical procedures, or amputation, or that resulted in death.

New events of arterial dissection reported as serious adverse events by sites.

Myocardial infarction reported as a serious adverse event by the sites.

Nerve damage events reported by the sites as serious adverse events that required retreatment.

Heart failure or hypotension reported as serious adverse events by the sites.

An increase of 5 mm or more in arterial diameter at the affected area compared to images taken at the first follow-up after initial treatment.

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 malfunctions

No flow or contrast detected through the implanted aortic or side branch devices or distal CTAG devices after the index endovascular procedure.

Longitudinal movement of all or part of the device for a distance ≥10 mm, as confirmed by CT scan, relative to anatomical landmarks and device positioning at the first post-operative CT scan.

Flow from a proximal aortic source through the primary intimal tear into the aortic false lumen (similar to a Type IA endoleak after treatment of aneurysms).

Among the aortic dissections reported by sites as serious adverse events, those in which proximal or distal progression of the lesion from the initial procedure was confirmed on imaging.

The thrombosis state of the false lumen at the treated and untreated segments at the initial 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.

TBE Zone 2 PMS in Japan

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?