Aortic AneurysmNCT02104089
Post-market Observational Study Zenith® t-Branch™
An observational study of Aortic Aneurysm and Thoracoabdominal, run by Cook Group Incorporated at 3 sites in 2 countries.
Trial summary
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Thoracoabdominal
- What is being tested?
- Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2014to 9 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Hospitals
Who may be able to join
- Treated with the off-the-shelf Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- Signed informed consent
Who cannot join
- Inability or refusal to give informed consent by the patient or a legally authorized representative
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Universitäts Krankenhaus Eppendorf
Hamburg, D-20246
St. Franziscus Hospital-GmbH
Münster, D-48145
About this study
Official title: Post-market Observational Study Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.
Read the detailed description
Both retrospective and prospective patients will be enrolled
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Being tested
- Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- Keywords
- Thoracoabdominal aortic aneurysm, Endovascular, Fenestration, Branch, Off-the-shelf
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® t-Branch™ Thoracoabdominal Endovascular GraftDevice
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment | Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Receives: Device: Zenith® t-Branch™ Thoracoabdominal Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mortality and morbidity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completion9 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni B Torsello, M.D., Principal investigator, St. Franziscus Hospital-GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104089
- Sponsor's protocol ID
- 12-017
- Status last verified
- Jan 2020
- First submitted
- 2 Apr 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
Publications
Tsilimparis N, Bosiers M, Resch T, Torsello G, Austermann M, Rohlffs F, Coates B, Yeh C, Kolbel T. Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Aug;78(2):289-298. doi: 10.1016/j.jvs.2023.03.498. Epub 2023 Apr 11.
PubMed 37044318Bosiers M, Kolbel T, Resch T, Tsilimparis N, Torsello G, Austermann M. Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. J Vasc Surg. 2021 Oct;74(4):1081-1089.e3. doi: 10.1016/j.jvs.2021.01.070. Epub 2021 Mar 5.
PubMed 33684474
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Observational Study Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- ClinicalTrials.gov ID
- NCT02104089
- Acronym / sponsor ID
- 12-017
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Keywords
- Thoracoabdominal aortic aneurysm, Endovascular, Fenestration, Branch, Off-the-shelf
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 4 Apr 2014 (estimated)
- 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.
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.
Detailed description
Both retrospective and prospective patients will be enrolled
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment | – | Device: Zenith® t-Branch™ Thoracoabdominal Endovascular GraftZenith® t-Branch™ Thoracoabdominal Endovascular Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitals
Key inclusion criteria (2 listed)
- Treated with the off-the-shelf Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- Signed informed consent
Key exclusion criteria (1 listed)
- Inability or refusal to give informed consent by the patient or a legally authorized representative
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 |
|---|---|---|
| Zenith® t-Branch™ Thoracoabdominal Endovascular GraftInstead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta. | Device | Endovascular treatment |
Primary outcome
Rate of mortality and morbidity
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 37044318Tsilimparis N, Bosiers M, Resch T, Torsello G, Austermann M, Rohlffs F, Coates B, Yeh C, Kolbel T. Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Aug;78(2):289-298. doi: 10.1016/j.jvs.2023.03.498. Epub 2023 Apr 11.
- Derived from this study: PubMed 33684474Bosiers M, Kolbel T, Resch T, Tsilimparis N, Torsello G, Austermann M. Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. J Vasc Surg. 2021 Oct;74(4):1081-1089.e3. doi: 10.1016/j.jvs.2021.01.070. Epub 2021 Mar 5.
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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.
Giovanni B Torsello, M.D. principal investigator
St. Franziscus Hospital-GmbH
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Thoracoabdominal, run by Cook Group Incorporated at 3 sites in 2 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 1 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: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of mortality and morbidity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02104089, which also lists 2 linked publications.
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 Jan 2020.