Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Last updated: February 25, 2026
Sponsor: Cook Research Incorporated
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Cardiovascular Disease

Heart Disease

Treatment

Endovascular aortic treatment

Clinical Study ID

NCT06094127
17-13
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has been treated/was intended to be treated with ZTA according to theclinical practice from Jan 2019 until site initiation

  • The patient is willing to participate in the study and provide written informedconsent for study participation or express non-objection or give written consent perlocal requirements prior to data collection of any data from medical records.

Exclusion

Exclusion Criteria:

  • A patient treated with a custom-made fenestrated and/or branched endovascular graftin 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 livingabroad).

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Endovascular aortic treatment
Phase:
Study Start date:
July 06, 2023
Estimated Completion Date:
December 01, 2034

Study 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.

Connect with a study center

  • CHU Dijon Bourgogne

    Dijon, 21079
    France

    Site Not Available

  • CHU Dijon Bourgogne

    Dijon 3021372, 21079
    France

    Site Not Available

  • Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph

    Le Plessis-Robinson, 92350
    France

    Site Not Available

  • Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph

    Le Plessis-Robinson 3002650, 92350
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59000
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire de Lille

    Lille 2998324, 59000
    France

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Universitätsklinikum der LMU München

    München, 81377
    Germany

    Site Not Available

  • Universitätsklinikum der LMU München

    München 2867711, 81377
    Germany

    Site Not Available

  • St. Franzikus Hospital Munster

    Münster, 48145
    Germany

    Site Not Available

  • St. Franzikus Hospital Munster

    Münster 2867543, 48145
    Germany

    Site Not Available

  • IRCCS-University Hospital Sant'Orsolo Polyclinic

    Bologna, 40138
    Italy

    Site Not Available

  • IRCCS-University Hospital Sant'Orsolo Polyclinic

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milan 6951411, 20132
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Maastricht University Medical Center

    Maastricht, 6202 AZ
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht 2751283, 6202 AZ
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen, 6500 HB
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen 2750053, 6500 HB
    Netherlands

    Site Not Available

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