Aneurysm ThoracicNCT07049913
TBE Zone 2 PMS in Japan
An observational study of Aneurysm Thoracic and Dissection of Aorta, Thoracic, run by W.L.Gore & Associates at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aneurysm Thoracic, Dissection of Aorta, Thoracic, Trauma
- What is being tested?
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- 15 Dec 2025to Feb 2034
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
The University of Osaka Hospital
Osaka, Suita, 565-0871
About this study
Official title: GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance in Japan
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
- Being tested
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Dissection, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore® TAG® Thoracic Aortic Branch Stent Graft SystemDevice
Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.
| Study group | Role | What they receive |
|---|---|---|
| TBE | Not described Receives: Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 60 Months
Serious Paraplegia
Paraplegia secondary to spinal cord ischemia reported as a serious adverse event from sites.
Measured: 60 Months
Serious Paraparesis
Paraparesis secondary to spinal cord ischemia reported as a serious adverse event from sites.
Measured: 60 Months
Renal Failure Requiring Dialysis
Renal failure reported as a serious adverse event by sites and confirmed to require dialysis.
Measured: 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.
Measured: 60 Months
Serious Device-related Ischemia
Ischemia reported by sites as a serious adverse event determined to be related to the device.
Measured: 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.
Measured: 60 Months
Serious New Dissection
New events of arterial dissection reported as serious adverse events by sites.
Measured: 60 Months
Serious Myocardial Infarction
Myocardial infarction reported as a serious adverse event by the sites.
Measured: 60 Months
Serious Laryngeal or Phrenic Nerve Injury
Nerve damage events reported by the sites as serious adverse events that required retreatment.
Measured: 60 Months
Serious Heart Failure/Hypotension
Heart failure or hypotension reported as serious adverse events by the sites.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Dec 2025
- Primary completionFeb 2034 (estimated)
- Study completionFeb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm ThoracicStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CMIC Co, Ltd. Japan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049913
- Sponsor's protocol ID
- JPS 25-01
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance in Japan
- ClinicalTrials.gov ID
- NCT07049913
- Acronym / sponsor ID
- JPS 25-01
- Conditions
- Aneurysm Thoracic, Dissection of Aorta, Thoracic, Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- CMIC Co, Ltd. Japan
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Feb 2034 (estimated)
- Study completion
- Feb 2034 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBE | – | Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gore® TAG® Thoracic Aortic Branch Stent Graft SystemPatients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance. | Device | TBE |
Primary outcome
Device Technical Success at the Initial Procedure
Time frame: 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
Aortic Rupture of the Treatment Lesion
Time frame: 60 Months
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
Lesion-related Mortality and All-cause Death
Time frame: 60 Months
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.
Disable Stroke
Time frame: 60 Months
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
Serious Paraplegia
Time frame: 60 Months
Paraplegia secondary to spinal cord ischemia reported as a serious adverse event from sites.
Serious Paraparesis
Time frame: 60 Months
Paraparesis secondary to spinal cord ischemia reported as a serious adverse event from sites.
Renal Failure Requiring Dialysis
Time frame: 60 Months
Renal failure reported as a serious adverse event by sites and confirmed to require dialysis.
Additional Unanticipated Post-procedural Surgical or Interventional Procedure
Time frame: 60 Months
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.
Serious Device-related Ischemia
Time frame: 60 Months
Ischemia reported by sites as a serious adverse event determined to be related to the device.
Distal Device-related Thromboembolic Serious Adverse Event Requiring Intervention or Surgery
Time frame: 60 Months
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.
Serious New Dissection
Time frame: 60 Months
New events of arterial dissection reported as serious adverse events by sites.
Serious Myocardial Infarction
Time frame: 60 Months
Myocardial infarction reported as a serious adverse event by the sites.
Serious Laryngeal or Phrenic Nerve Injury
Time frame: 60 Months
Nerve damage events reported by the sites as serious adverse events that required retreatment.
Serious Heart Failure/Hypotension
Time frame: 60 Months
Heart failure or hypotension reported as serious adverse events by the sites.
Aortic Enlargement in the Region Encompassed by the Initial Lesion
Time frame: 60 Months
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.
Endoleak
Time frame: 60 Months
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.
Loss of Device Integrity
Time frame: 60 Months
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
Loss of Aortic or Aortic Branch Patency
Time frame: 60 Months
No flow or contrast detected through the implanted aortic or side branch devices or distal CTAG devices after the index endovascular procedure.
Migration
Time frame: 60 Months
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.
False Lumen Perfusion through the Primary Entry Tear (Dissection Patients only)
Time frame: 60 Months
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).
Extension of a Dissection (Proximally or Distally) (Dissection Patients only)
Time frame: 60 Months
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.
False Lumen Status in Treated and Untreated Segments (Dissection Patients only)
Time frame: 60 Months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Thoracic and Dissection of Aorta, Thoracic, run by W.L.Gore & Associates at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hideyuki Saigusa (819039126169, hsaigusa@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Technical Success at the Initial Procedure (time frame: Initial procedure). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.