Active — Not RecruitingNot Applicable

Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

France, Germany300 participantsStarted 2023-07-06

Plain-language summary

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.

Who can participate

SexALL

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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).

What they're measuring

freedom from aortic-disease-related mortality

Timeframe: 5 years

Trial details

NCT IDNCT06094127

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-12-01

View on ClinicalTrials.gov More Thoracic Aortic Aneurysm trials