TBE Zone 0/1 PMS in Japan

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Market Surveillance in Japan

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma; Dissection of Aorta, Thoracic; Aneurysm of Aorta, Thoracic
• Intervention / Treatment: Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Manami Kaneko; Phone Number: +81-70-1433-0565; Email: mkaneko@wlgore.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

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.

• Thoracic aortic aneurysm
• Traumatic transection
• Complicated Stanford type A (after surgical repair) and B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy

The GORE® TAG® Thoracic Branch Endoprosthesis may be used in combination with designated stent grafts with validated efficacy and safety.

Exclusion Criteria:

N/A

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aneurysm cohort; 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; 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).
Dissection and Traumatic Transection cohort; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 Months
Serious Paraplegia	Paraplegia secondary to spinal cord ischemia reported as a serious adverse event from sites.	60 Months
Serious Paraparesis	Paraparesis secondary to spinal cord ischemia reported as a serious adverse event from sites.	60 Months
Renal Failure Requiring Dialysis	Renal failure reported as a serious adverse event by sites and confirmed to require dialysis.	60 Months
Serious Device-related Ischemia	Ischemia reported by sites as a serious adverse event determined to be related to the device.	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.	60 Months
Serious Myocardial Infarction	Myocardial infarction reported as a serious adverse event by the sites.	60 Months
Serious Laryngeal or Phrenic Nerve Injury	Nerve damage events reported by the sites as serious adverse events that required retreatment.	60 Months
Serious Heart Failure/Hypotension	Heart failure or hypotension reported as serious adverse events by the sites.	60 Months
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	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.	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	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.	60 Months
Serious New Dissection	New events of aortic dissection reported as serious adverse events by sites.	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.	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.	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	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.	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.	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.	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.	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.	60 Months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Collaborators: CMIC Co, Ltd. Japan

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2035

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Wounds and Injuries; Aortic Aneurysm; Aortic Dissection
• Other Study ID Numbers: JPS 25-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes