Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

February 25, 2026 updated by: Cook Research Incorporated

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu Dijon Bourgogne
      • Le Plessis-Robinson, France, 92350
        • Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph
      • Lille, France, 59000
        • Centre Hospitalier Régional Universitaire de Lille
  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • München, Germany, 81377
        • Universitätsklinikum der LMU München
      • Münster, Germany, 48145
        • St. Franzikus Hospital Munster
  • Italy
      • Bologna, Italy, 40138
        • IRCCS-University Hospital Sant'Orsolo Polyclinic
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht University Medical Center
      • Nijmegen, Netherlands, 6500 HB
        • Radboud UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will collect clinical data on patients treated with ZTA. Data from at least 300 eligible patients will be collected, among them a minimum of 196 patients with primary pathology being aneurysm or penetrating aortic ulcer of the descending thoracic aorta. Patients treated with ZTA will be consecutively enrolled in the study and the enrollment of all patients will be completed at maximum year after site activation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
freedom from aortic-disease-related mortality
Time Frame: 5 years
Death from aortic rupture; death from any cause occurring within 30 days of the index procedure or a secondary intervention; or any death determined to be related to the treated aortic disease
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Research Incorporated

Investigators

  • Principal Investigator: Nikolaos Tsilimparis, MD, Klinikum der Universität München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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