TAMBE Japan Post-Marketing Surveillance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorW.L.Gore & Associates

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who were attempted to implant the AC

Thoracoabdominal aortic aneurysm

Pararenal abdominal aortic aneurysm

Disqualifiers

N/A

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: TAMBE1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From the initial incision or puncture of the access vessel for the implantation procedure to the closure of the access vessel
2

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

Time frame
12 Months
3

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

Time frame
60 Months
4

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).

Time frame
60 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

W.L.Gore & Associates

Lead sponsor

CMIC Co, Ltd. Japan

Collaborator