ClinicalTrials.gg
Active, not recruitingNCT06094127Updated Feb 27, 2026

Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

An observational study in Thoracic Aortic Aneurysm and Penetrating Aortic Ulcer, sponsored by Cook Research Incorporated. Active, not recruiting at 10 sites in 4 countries. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Cook Research Incorporated (part of Cook Group Incorporated) · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Thoracic Aortic Aneurysm
  • Penetrating Aortic Ulcer

Keywords

  • Aneurysm
  • Thoracic
  • Descending
  • Aorta
  • Stent-graft
03

In context

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's planned enrollment of 300 is above the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

Cook Research Incorporated is the lead sponsor of 33 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • DeviceEndovascular aortic treatment

    Use of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer.

06

What researchers measure

Primary outcomes

  1. freedom from aortic-disease-related mortality

    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

    Time frame: 5 years

07

Study locations

10 sites
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06094127
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Jul 6, 2023
Primary completion
Dec 1, 2029 (estimated)
Completion
Dec 1, 2034 (estimated)
Last update
Feb 27, 2026

Study contacts

Nikolaos Tsilimparis, MD
principal investigator · Klinikum der Universitat Munchen

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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