TAMBE Japan Post-Marketing Surveillance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2034-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Thoracoabdominal Aortic Aneurysm Pararenal Aortic Aneurysm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TAMBE

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE