Thoracoabdominal Aortic AneurysmNCT07147569
TAMBE Japan Post-Marketing Surveillance
An observational study of Thoracoabdominal Aortic Aneurysm and Pararenal Aortic Aneurysm, run by W.L.Gore & Associates at 5 sites in Japan.
Trial summary
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
- What is being tested?
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesJapan
- Study dates
- 27 Mar 2026to 28 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: The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.
Who may be able to join
- Patients who were attempted to implant the AC
- Thoracoabdominal aortic aneurysm
- Pararenal abdominal aortic aneurysm
Who cannot join
- N/A
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
The Jikei University Hospital
Minatoku
- Recruiting
Nagoya University Hospital
Nagoya
- Recruiting
Morinomiya Hospital
Osaka
- Recruiting
Osaka International Medical & Science Center Osaka Police Hospital
Osaka
- Recruiting
The University of Osaka Hospital
Suita
About this study
Official title: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
- Being tested
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® EXCLUDER® Thoracoabdominal Branch EndoprosthesisDevice
The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.
| Study group | Role | What they receive |
|---|---|---|
| TAMBE | Not described Receives: Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Calculate the rate of achievement of technical success at the index procedure. The technical success is defined as follows.
[Technical success]
All of the following qualifying criteria are met:
- Successful access to the access vessels
- Successful delivery and deployment of AC and all stent grafts used in combination with AC to its intended location
- Successful side branch delivery catheterization and placement of all stent grafts used in the side branch area to its intended location
- Absence of type I or type III endoleaks at final completion image evaluation
- Patency of AC and all stent grafts used in combination with AC at final completion image evaluation
- Absence of open surgical repair conversion or mortality
Measured: From the initial incision or puncture of the access vessel for the implantation procedure to the closure of the access vessel
Clinical Success
The achievement rate of clinical success will be calculated. The clinical success is defined as follows.
[Clinical Success]
- Achievement of technical success
- Absence of the events listed below from the time of the index procedure to 12 months after the index procedure
- Death from the index procedure
- Death from reintervention
- Death from aorta-related causes
- Persistent type I or type III endoleaks
- Lesion enlargement >5 mm
- Device migration >10 mm
- Failure due to device integrity issues
- Lesion rupture
- Conversion to open surgical repair
- Permanent paraplegia
- Disabling stroke
- New-onset dialysis
Measured: 12 Months
Results related to abdominal branch vessels
Calculate the incidence of the following events related to abdominal branch vessels (celiac artery, superior mesenteric artery, left/ right renal arteries) or AC and stent grafts used in combination with AC for visceral branch vessels.
- Primary Patency
- Primary Assisted Patency
- Secondary Patency
- Occlusion
- Stenosis
- Kink
- Target vessel instability
- Intraprocedural Complications
Measured: 60 Months
Major Adverse Events (MAEs)
The incidence of any of following events is calculated.
- All-cause mortality
- Myocardial infarction resulting in death, cardiac arrest, or cardiopulmonary resuscitation
- Respiratory failure requiring prolonged (> 24 hours) mechanical ventilation or reintubation
- Renal function decline characterized by one or more of the following:
- > 50% reduction in pre-treatment Estimated Glomerular Filtration Rate (eGFR)
- New-onset dialysis
- Bowel ischemia requiring surgical resection or not resolving with medical therapy
- Permanent paraplegia
- Major stroke (Any fatal or disabling stroke).
Measured: 60 Months
Thirty-Day Mortality
Calculate thirty-day mortality. Thirty-day mortality is defined as follows.
[Thirty-Day Mortality]
Any death that occurs at the index procedure, within the index procedure hospital stay, or within the first 30 days post-index procedure.
Measured: 30 Days
Lesion-Related Mortality
Calculate lesion-related mortality. Lesion-related mortality is defined as follows.
[Lesion-related mortality]
Any death that occurs within the first 30 days, any death that results from lesion rupture, aorta-related adverse events (e.g., infection, occlusion, dissection, hematoma), or adverse events related to a secondary intervention.
Measured: 30 Days
Reintervention
Calculate the incidence of reintervention. Reintervention will be classified as "major" or "minor". Reintervention and its classifications are defined as follows.
[Reintervention]
Any procedure after the index procedure on the AC and stent grafts used in combination with AC.
[Major Reintervention]
Deployment the stent graft for proximal or distal side, removal of AC and stent grafts used in combination with AC, use of thrombectomy or thrombolysis, and surgical procedure.
[Minor Reintervention]
Treatment other than major reintervention that falls under any of the following categories
- Endovascular procedures (percutaneous transluminal angioplasty, atherectomy, stenting)
- Interventions to treat branch vessel stenosis
- Interventions to treat type II endoleaks or branch-related endoleaks.
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 posted29 Aug 2025
- Study start27 Mar 2026
- Primary completion28 Feb 2034 (estimated)
- Study completion28 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic AneurysmStudies 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
- 100 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
- NCT07147569
- Sponsor's protocol ID
- JPS 25-02
- Status last verified
- May 2026
- First submitted
- 19 Aug 2025
- Last updated
- 5 May 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT07147569
- Acronym / sponsor ID
- JPS 25-02
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- CMIC Co, Ltd. Japan
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 28 Feb 2034 (estimated)
- Study completion
- 28 Feb 2034 (estimated)
- First posted
- 29 Aug 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.
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAMBE | – | Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.
Key inclusion criteria (3 listed)
- Patients who were attempted to implant the AC
- Thoracoabdominal aortic aneurysm
- Pararenal abdominal aortic aneurysm
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® EXCLUDER® Thoracoabdominal Branch EndoprosthesisThe target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used. | Device | TAMBE |
Primary outcome
Technical Success
Time frame: From the initial incision or puncture of the access vessel for the implantation procedure to the closure of the access vessel
Calculate the rate of achievement of technical success at the index procedure. The technical success is defined as follows. [Technical success] All of the following qualifying criteria are met: * Successful access to the access vessels * Successful delivery and deployment of AC and all stent grafts used in combination with AC to its intended location * Successful side branch delivery catheterization and placement of all stent grafts used in the side branch area to its intended location * Absence of type I or type III endoleaks at final completion image evaluation * Patency of AC and all stent grafts used in combination with AC at final completion image evaluation * Absence of open surgical repair conversion or mortality
Clinical Success
Time frame: 12 Months
The achievement rate of clinical success will be calculated. The clinical success is defined as follows. [Clinical Success] * Achievement of technical success * Absence of the events listed below from the time of the index procedure to 12 months after the index procedure 1. Death from the index procedure 2. Death from reintervention 3. Death from aorta-related causes 4. Persistent type I or type III endoleaks 5. Lesion enlargement >5 mm 6. Device migration >10 mm 7. Failure due to device integrity issues 8. Lesion rupture 9. Conversion to open surgical repair 10. Permanent paraplegia 11. Disabling stroke 12. New-onset dialysis
Results related to abdominal branch vessels
Time frame: 60 Months
Calculate the incidence of the following events related to abdominal branch vessels (celiac artery, superior mesenteric artery, left/ right renal arteries) or AC and stent grafts used in combination with AC for visceral branch vessels. * Primary Patency * Primary Assisted Patency * Secondary Patency * Occlusion * Stenosis * Kink * Target vessel instability * Intraprocedural Complications
Major Adverse Events (MAEs)
Time frame: 60 Months
The incidence of any of following events is calculated. * All-cause mortality * Myocardial infarction resulting in death, cardiac arrest, or cardiopulmonary resuscitation * Respiratory failure requiring prolonged (> 24 hours) mechanical ventilation or reintubation * Renal function decline characterized by one or more of the following: 1. > 50% reduction in pre-treatment Estimated Glomerular Filtration Rate (eGFR) 2. New-onset dialysis * Bowel ischemia requiring surgical resection or not resolving with medical therapy * Permanent paraplegia * Major stroke (Any fatal or disabling stroke).
Thirty-Day Mortality
Time frame: 30 Days
Calculate thirty-day mortality. Thirty-day mortality is defined as follows. [Thirty-Day Mortality] Any death that occurs at the index procedure, within the index procedure hospital stay, or within the first 30 days post-index procedure.
Lesion-Related Mortality
Time frame: 30 Days
Calculate lesion-related mortality. Lesion-related mortality is defined as follows. [Lesion-related mortality] Any death that occurs within the first 30 days, any death that results from lesion rupture, aorta-related adverse events (e.g., infection, occlusion, dissection, hematoma), or adverse events related to a secondary intervention.
Reintervention
Time frame: 60 Months
Calculate the incidence of reintervention. Reintervention will be classified as "major" or "minor". Reintervention and its classifications are defined as follows. [Reintervention] Any procedure after the index procedure on the AC and stent grafts used in combination with AC. [Major Reintervention] Deployment the stent graft for proximal or distal side, removal of AC and stent grafts used in combination with AC, use of thrombectomy or thrombolysis, and surgical procedure. [Minor Reintervention] Treatment other than major reintervention that falls under any of the following categories * Endovascular procedures (percutaneous transluminal angioplasty, atherectomy, stenting) * Interventions to treat branch vessel stenosis * Interventions to treat type II endoleaks or branch-related endoleaks.
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 May 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoabdominal Aortic Aneurysm and Pararenal Aortic Aneurysm, run by W.L.Gore & Associates at 5 sites 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 3 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Katsuyuki Niwa (+819017754499, kniwa@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: From the initial incision or puncture of the access vessel for the implantation procedure to the closure of the access vessel). The study lists 7 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 May 2026.