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300 patients tracked to see if aortic stent holds up over time

NCT ID NCT06094127

Knowledge-focused Sponsor: Cook Research Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 300 people who already received a Zenith® Alpha Thoracic Endovascular Graft to treat a thoracic aortic aneurysm or ulcer. Researchers are checking how well the device works and how safe it is over the long term, especially looking at deaths related to the aortic disease. The goal is to gather real-world data to confirm the device's performance over its expected lifetime.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Aneurysm Penetrating Atherosclerotic Ulcer thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Penetrating aortic ulcer Thoracic aortic aneurysm

Contacts and locations

Locations

  • CHU Dijon Bourgogne

    Dijon, 21079, France

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59000, France

  • Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph

    Le Plessis-Robinson, 92350, France

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • IRCCS-University Hospital Sant'Orsolo Polyclinic

    Bologna, 40138, Italy

  • Maastricht University Medical Center

    Maastricht, 6202 AZ, Netherlands

  • Radboud UMC

    Nijmegen, 6500 HB, Netherlands

  • St. Franzikus Hospital Munster

    Münster, 48145, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum der LMU München

    München, 81377, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.