Recruiting NCT07147569

TAMBE Japan Post-Marketing Surveillance

— Observational Thoracoabdominal Aortic Aneurysm Pararenal Aortic Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis.
Who it may be relevant to: Registry conditions: Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Japan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance

Overview

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.

Interventions

Device GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
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.

Primary outcome measures

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]
Clinical Success [Time frame: 12 Months]
Results related to abdominal branch vessels [Time frame: 60 Months]
Major Adverse Events (MAEs) [Time frame: 60 Months]
Thirty-Day Mortality [Time frame: 30 Days]
Lesion-Related Mortality [Time frame: 30 Days]
Reintervention [Time frame: 60 Months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-only

Study locations

Japan · 5 centers

The Jikei University Hospital — Minatoku
Nagoya University Hospital — Nagoya
Morinomiya Hospital — Osaka
Osaka International Medical & Science Center Osaka Police Hospital — Osaka
The University of Osaka Hospital — Suita

Identifiers

NCT: NCT07147569 · JPS 25-02

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗