Thoracic Aortic AneurysmNCT06094127
Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
An observational study of Thoracic Aortic Aneurysm and Penetrating Aortic Ulcer, run by Cook Research Incorporated at 10 sites in 4 countries.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
- What is being tested?
- Endovascular aortic treatment
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 6 Jul 2023to 1 Dec 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
France3 sites
CHU Dijon Bourgogne
Dijon, 21079
Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph
Le Plessis-Robinson, 92350
Centre Hospitalier Regional Universitaire de Lille
Lille, 59000
Germany3 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitätsklinikum der LMU München
München, 81377
St. Franzikus Hospital Munster
Münster, 48145
Italy2 sites
IRCCS-University Hospital Sant'Orsolo Polyclinic
Bologna, 40138
IRCCS Ospedale San Raffaele
Milan, 20132
Netherlands2 sites
Maastricht University Medical Center
Maastricht, 6202 AZ
Radboud UMC
Nijmegen, 6500 HB
About this study
Official title: 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.
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.
- Conditions
- Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
- Being tested
- Endovascular aortic treatment
- Keywords
- Aneurysm, Thoracic, Descending, Aorta, Stent-graft
- Medical subject headings
- Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular aortic treatmentDevice
Use of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start6 Jul 2023
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikolaos Tsilimparis, MD, Principal investigator, Klinikum der Universitat Munchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094127
- Sponsor's protocol ID
- 17-13
- Status last verified
- Feb 2026
- First submitted
- 17 Oct 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Clinical Follow up Study on Cook Medical Zenith® Alpha Thoracic Endovascular Grafts
- ClinicalTrials.gov ID
- NCT06094127
- Acronym / sponsor ID
- 17-13
- Conditions
- Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
- Keywords
- Aneurysm, Thoracic, Descending, Aorta, Stent-graft
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2034 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular aortic treatmentUse of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer. | Device | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Tsilimparis, MD principal investigator
Klinikum der Universitat Munchen
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm and Penetrating Aortic Ulcer, run by Cook Research Incorporated at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Germany, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom from aortic-disease-related mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.