Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Recruiting

• Conditions: Penetrating Aortic Ulcer; Thoracic Aortic Aneurysm

• Registration Number: NCT06094127
• Lead Sponsor: Cook Research Incorporated

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 longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.

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 the study site is eligible for prospective enrollment.

Study Timeline

• Study Start: 2023-07-06
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2029-10-01
• Study Completion: 2034-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from aneurysm-related mortality	5 years	Death related to aneurysm

Trial Locations

Locations (10)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitätsklinikum der LMU München; 🇩🇪 München, Germany

IRCCS-University Hospital Sant'Orsolo Polyclinic; 🇮🇹 Bologna, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Radboud UMC; 🇳🇱 Nijmegen, Netherlands

Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph; 🇫🇷 Le Plessis-Robinson, France

Centre Hospitalier Regional Universitaire de Lille; 🇫🇷 Lille, France

St. Franzikus Hospital Munster; 🇩🇪 Münster, Germany