TBE Zone 2 PMS in Japan

NCT07049913 | Recruiting FDA Device

• 1 other identifier: JPS 25-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aneurysm Thoracic; Dissection of Aorta, Thoracic; Trauma

Outcome Measures

Primary Outcomes (22)

• Device Technical Success at the Initial 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, procedure, or withdrawal of the delivery system

  Initial procedure

• 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

• Lesion-related Mortality and All-cause Death

  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.

  60 Months

• Disable 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

• 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

• Additional Unanticipated Post-procedural Surgical or Interventional Procedure

  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.

  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 New Dissection

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

  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

• Aortic Enlargement in the Region Encompassed by the Initial Lesion

  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.

  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 malfunctions

  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 index endovascular procedure.

  60 Months

• Migration

  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.

  60 Months

• False Lumen Perfusion through the Primary Entry Tear (Dissection Patients only)

  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).

  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 initial 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 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.

  60 Months

Study Arms (1)

TBE

Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System

Interventions

Gore® TAG® Thoracic Aortic Branch Stent Graft System DEVICE

Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.

TBE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.

You may qualify if:

• 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 with descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to the left subclavian artery.
• Thoracic aortic aneurysm,
• Traumatic transection, and
• Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy.

You may not qualify if:

• N/A

Sponsors & Collaborators

• W.L.Gore & Associates: lead
• CMIC Co, Ltd. Japan: collaborator

Study Sites (1)

The University of Osaka Hospital

Osaka, Suita, 565-0871, Japan

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Dissection; Wounds and Injuries

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Central Study Contacts

Hideyuki Saigusa

CONTACT

819039126169; hsaigusa@wlgore.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2034
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)