Status:
RECRUITING
Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
Lead Sponsor:
Cook Research Incorporated
Conditions:
Thoracic Aortic Aneurysm
Penetrating Aortic Ulcer
Eligibility:
All Genders
Brief 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 long...
Detailed 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 th...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2034
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06094127
Start Date
July 6 2023
End Date
December 1 2034
Last Update
January 7 2026
Active Locations (10)
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1
CHU Dijon Bourgogne
Dijon, France, 21079
2
Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph
Le Plessis-Robinson, France, 92350
3
Centre Hospitalier Regional Universitaire de Lille
Lille, France, 59000
4
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246