Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Cook Group

Status: Enrolling

Conditions: Penetrating Aortic Ulcer; Thoracic Aortic Aneurysm

Treatments: Device: Endovascular aortic treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT06094127

17-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).