Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

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

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-06

Study Completion Date

2034-12-01

Brief Summary

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This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft \[ZTA\]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.

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Detailed Description

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Per local regulations, this study includes both retrospective and prospective patients. Patients can be included retrospectively if they are treated with the study device from 01 January 2019 until the study site is eligible for prospective enrollment.

Conditions

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Thoracic Aortic Aneurysm Penetrating Aortic Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Endovascular aortic treatment

Use of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has been treated/was intended to be treated with ZTA according to the clinical practice from Jan 2019 until site initiation
* The patient is willing to participate in the study and provide written informed consent for study participation or express non-objection or give written consent per local requirements prior to data collection of any data from medical records.

Exclusion Criteria

* A patient treated with a custom-made fenestrated and/or branched endovascular graft in conjunction with ZTA either during the same procedure or in a staged procedure.
* A patient whose follow-up data collection is not possible (e.g. due to living abroad).

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikolaos Tsilimparis, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universitat Munchen

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING