TAMBE Japan Post-Marketing Surveillance

NCT07147569 | Recruiting FDA Device

• 1 other identifier: JPS 25-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Thoracoabdominal Aortic Aneurysm; Pararenal Aortic Aneurysm

Outcome Measures

Primary Outcomes (7)

• 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

  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 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

  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

  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: 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).

  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.

  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.

  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.

  60 Months

Study Arms (1)

TAMBE

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Interventions

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis DEVICE

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.

TAMBE

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

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.

You may qualify if:

• Patients who were attempted to implant the AC
• Thoracoabdominal aortic aneurysm
• Pararenal abdominal aortic aneurysm

You may not qualify if:

• N/A

Sponsors & Collaborators

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

Study Sites (5)

The Jikei University Hospital

Minatoku, Japan

RECRUITING

Nagoya University Hospital

Nagoya, Japan

RECRUITING

Morinomiya Hospital

Osaka, Japan

RECRUITING

Osaka International Medical & Science Center Osaka Police Hospital

Osaka, Japan

RECRUITING

The University of Osaka Hospital

Suita, Japan

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Katsuyuki Niwa

CONTACT

+819017754499; kniwa@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: August 19, 2025
• First Posted: August 29, 2025
• Study Start: March 27, 2026
• Primary Completion (Estimated): February 28, 2034
• Study Completion (Estimated): February 28, 2034
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)