Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Thoracic Aortic Aneurysm Clinical Trial

Official title:

A Post-market Clinical Follow up Study on Cook Medical Zenith® Alpha Thoracic Endovascular Grafts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094127
• Other study ID #: 17-13
• Status: Recruiting
• Start date: July 6, 2023
• Est. completion date: October 1, 2034

Study information

• Verified date: October 2023
• Source: Cook Group Incorporated
• Contact: Pedro Ribelles
• Phone: +33660523152
• Email: pedro.ribelles[@]cookmedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 1, 2034
• Est. primary completion date: October 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Penetrating Aortic Ulcer
• Thoracic Aortic Aneurysm

Intervention

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

Locations

Country	Name	City	State
France	Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph	Le Plessis-Robinson
France	Centre Hospitalier Regional Universitaire de Lille	Lille
Germany	St. Franzikus Hospital Munster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from aneurysm-related mortality	Death related to aneurysm	5 years