Aortic Archtriple_branchNCT05530304
Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.
An observational study of Aortic Arch and Aortic Arch Aneurysm, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Arch, Aortic Arch Aneurysm, Dissection of Aortic Arch
- What is being tested?
- Triple inner branched arch stentgraft
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 9 Feb 2023to 31 Mar 2027
- How long will I take part?
- 1 Year
- 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: Study participants will be recruited from patients presenting to participating hospitals with aortic pathology and meeting inclusion and exclusion criteria.
Who may be able to join
- 18 years or older
- Presence of Aortic arch pathology
- Treatment planned with triple inner branch from Terumo Aortic
- Availability of the patients during the follow up period
- Informing patients about the study and providing written informed consent
Who cannot join
- Women of childbearing age
- Patients under 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Muenster University Hospital
Münster
Alexander Oberhuber, MD Phd, +49 251 8345781, alexander.oberhuber@ukmuenster.de
Alexander Oberhuber, MD Phd
About this study
Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.
- Being tested
- Triple inner branched arch stentgraft
- Keywords
- Aortic arch pathologies, Aortic arch aneruysm, Aortic arch dissection, triple branch, stentgraft, Double branch, Inner branch
- Medical subject headings
- Aneurysm, Aortic Arch, Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple inner branched arch stentgraftDevice
New findings regarding treatment planning and management of patients with aortic arch pathologies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days after intervention
feasibility in terms of cannulation and stentgrafting of the three branches
Measured: During intervention
Stroke
Measured: 30 days after intervention
Secondary outcomes (5)
Morbidity
Access issue, paraplegia, kidney failure
Measured: during the follow up period of 3 year
Endoleaks Type I and III
Measured: during intervention and the follow up period of 3 year
Longterm mortality
Measured: during the follow up period of 3 year
Patency rate of branches
primary and secondary
Measured: during the follow up period of 3 year
Stroke
Measured: during the follow up period of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start9 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic ArchStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Dr. med. Alexander Oberhuber, University Hospital Muenster
- Investigators
- Alexander Oberhuber, MD, PhD, Study chair, Department of Vascular and Endovascular Surgery University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530304
- Sponsor's protocol ID
- University_Hospital_Muenster
- Acronym
- triple_branch
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.
- ClinicalTrials.gov ID
- NCT05530304
- Acronym / sponsor ID
- triple_branch / University_Hospital_Muenster
- Keywords
- Aortic arch pathologies, Aortic arch aneruysm, Aortic arch dissection, triple branch, stentgraft, Double branch, Inner branch
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Sep 2022 (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.
Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be recruited from patients presenting to participating hospitals with aortic pathology and meeting inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- 18 years or older
- Presence of Aortic arch pathology
- Treatment planned with triple inner branch from Terumo Aortic
- Availability of the patients during the follow up period
- Informing patients about the study and providing written informed consent
Key exclusion criteria (2 listed)
- Women of childbearing age
- Patients under 18 years
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 |
|---|---|---|
| Triple inner branched arch stentgraftNew findings regarding treatment planning and management of patients with aortic arch pathologies. | Device | – |
Primary outcome
Mortality
Time frame: 30 days after intervention
feasibility in terms of cannulation and stentgrafting of the three branches
Time frame: During intervention
Stroke
Time frame: 30 days after intervention
5 secondary outcomes
Morbidity
Time frame: during the follow up period of 3 year
Endoleaks Type I and III
Time frame: during intervention and the follow up period of 3 year
Longterm mortality
Time frame: during the follow up period of 3 year
Patency rate of branches
Time frame: during the follow up period of 3 year
Stroke
Time frame: during the follow up period of 3 year
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 13 Sep 2023.
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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.
Alexander Oberhuber, MD, PhD study chair
Department of Vascular and Endovascular Surgery University Hospital Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Arch and Aortic Arch Aneurysm, run by University Hospital Muenster at 1 site in Germany.
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 5 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: looking for participants now, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Contact Alexander Oberhuber, MD, PhD (+49 251 8345781, alexander.oberhuber@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days after intervention). The study lists 3 primary outcomes in all. 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 13 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.