An observational study in Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic and Trauma, sponsored by W.L.Gore & Associates. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by W.L.Gore & Associates · Observational
The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 75 is below the median of 150 across 117 observational studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who attempted implant of TBE in Zone 0/1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0/1 area).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Those who are suitable for use of TBE according to the Japan package insert. [Reference: Purpose of Use or Effects of TBE at the time of launch] The GORE® TAG® Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases of the aortic arch and descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to a single aortic arch target branch vessel.
The GORE® TAG® Thoracic Branch Endoprosthesis may be used in combination with designated stent grafts with validated efficacy and safety.
Exclusion Criteria:
N/A
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.
Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System
* 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.
Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System
Patients who attempted implant of TBE in Zone 0/1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0/1 area).
Device Technical Success at the Initial Endovascular Procedure
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
Time frame: TBE Initial Implant Procedure
Lesion-related Mortality and All-cause Death
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.
Time frame: 60 Months
Aortic Rupture of the Treatment Lesion
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
Time frame: 60 Months
Disabling Stroke
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
Time frame: 60 Months
Serious Paraplegia
Paraplegia secondary to spinal cord ischemia reported as a serious adverse event from sites.
Time frame: 60 Months
Serious Paraparesis
Paraparesis secondary to spinal cord ischemia reported as a serious adverse event from sites.
Time frame: 60 Months
Renal Failure Requiring Dialysis
Renal failure reported as a serious adverse event by sites and confirmed to require dialysis.
Time frame: 60 Months
Additional Unanticipated Post-procedural Reintervention
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.
Time frame: 60 Months
Serious Device-related Ischemia
Ischemia reported by sites as a serious adverse event determined to be related to the device.
Time frame: 60 Months
Distal Device-related Thromboembolic Serious Adverse Event Requiring Intervention or Surgery
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.
Time frame: 60 Months
Serious New Dissection
New events of aortic dissection reported as serious adverse events by sites.
Time frame: 60 Months
Serious Myocardial Infarction
Myocardial infarction reported as a serious adverse event by the sites.
Time frame: 60 Months
Serious Laryngeal or Phrenic Nerve Injury
Nerve damage events reported by the sites as serious adverse events that required retreatment.
Time frame: 60 Months
Serious Heart Failure/Hypotension
Heart failure or hypotension reported as serious adverse events by the sites.
Time frame: 60 Months
Aortic Enlargement in the Region Encompassed by the Initial Lesion
An increase of 5 mm or more in arterial diameter at the treated area compared to images taken at the first follow-up after the TBE implant procedure.
Time frame: 60 Months
Endoleak
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.
Time frame: 60 Months
Loss of Device Integrity
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
Time frame: 60 Months
Loss of Aortic or Aortic Branch Patency
No flow or contrast detected through the implanted aortic or side branch devices or distal CTAG devices after the TBE implant procedure.
Time frame: 60 Months
Migration
Longitudinal movement of all or part of the device for a distance ≥10 mm, as confirmed by imaging, relative to anatomical landmarks and device positioning at the first post-operative imaging.
Time frame: 60 Months
False Lumen Perfusion through the Primary Entry Tear (Dissection Patients only)
Confirm the presence or absence of blood flow from a proximal aortic source through the primary entry tear into the aortic false lumen, based on imaging.
Time frame: 60 Months
Extension of a Dissection (Proximally or Distally) (Dissection Patients only)
Among the aortic dissections reported by sites as serious adverse events, those in which proximal or distal progression of the lesion from the TBE implant procedure was confirmed on imaging.
Time frame: 60 Months
False Lumen Status in Treated and Untreated Segments (Dissection Patients only)
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.
Time frame: 60 Months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2035, 108 months later.
Of 44 observational studies under Aortic Aneurysm, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 107. This study's planned 108 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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