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NCT06094127 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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).

Study Design

Related Conditions & MeSH terms

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
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