Aortic AneurysmNCT06059053
Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
An observational study of Aortic Aneurysm and Endovascular Aortic Repair, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Endovascular Aortic Repair, Stent-Graft Endoleak
- What is being tested?
- Semibranch CMD branched aortic stentgraft
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jan 2024to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft.
Who may be able to join
- 18 years or older
- Presence of pararenal or thoracoabdominal aortic pathology
- Treatment planned a semibranch device branch from Artivion
- 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
The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.
Read the detailed description
The main question it aims to answer are:
- Patency of the semibranch
- Feasibility of the technique regarding cannulation and stentgrafting
The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.
- Being tested
- Semibranch CMD branched aortic stentgraft
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semibranch CMD branched aortic stentgraftDevice
bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from target vessel instability
primary patency and freedom from stenosis fo the semibranch
Measured: 30 days after intervention
Mortality
overall mortality rate during 30 days after intervention
Measured: 30 days after intervention
technical success
Feasibility in terms of cannulation and stentgrafting of the semibranches
Measured: During intervention
Secondary outcomes (4)
Morbidity
Access site, bowel ischemia, kidney failure, paraplegia
Measured: During follow up period (up to 3 years)
freedom Endoleak Type I and III
absence of endoleaks arising from the semibranch
Measured: During follow up period (up to 3 years)
Long term mortality
overall mortality up to 3 years
Measured: During follow up period (up to 3 years)
Branch patency
primary patency of all branches
Measured: During follow up period (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start12 Jan 2024
- 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 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
- Prospective
- Enrolment
- 100 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 MünsterAlexander Oberhuber, MD,PhD, Principal investigator, Department of Vascular and Endovascular Surgery University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059053
- Sponsor's protocol ID
- Semibranch_Reg
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
- ClinicalTrials.gov ID
- NCT06059053
- Acronym / sponsor ID
- Semibranch_Reg
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Sep 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.
The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.
Detailed description
The main question it aims to answer are:
- Patency of the semibranch
- Feasibility of the technique regarding cannulation and stentgrafting
The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft.
Key inclusion criteria (5 listed)
- 18 years or older
- Presence of pararenal or thoracoabdominal aortic pathology
- Treatment planned a semibranch device branch from Artivion
- 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 |
|---|---|---|
| Semibranch CMD branched aortic stentgraftbEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design | Device | – |
Primary outcome
Freedom from target vessel instability
Time frame: 30 days after intervention
primary patency and freedom from stenosis fo the semibranch
Mortality
Time frame: 30 days after intervention
overall mortality rate during 30 days after intervention
technical success
Time frame: During intervention
Feasibility in terms of cannulation and stentgrafting of the semibranches
4 secondary outcomes
Morbidity
Time frame: During follow up period (up to 3 years)
freedom Endoleak Type I and III
Time frame: During follow up period (up to 3 years)
Long term mortality
Time frame: During follow up period (up to 3 years)
Branch patency
Time frame: During follow up period (up to 3 years)
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 26 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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
Alexander Oberhuber, MD,PhD principal investigator
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 Aneurysm and Endovascular Aortic Repair, 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 26 Mar 2024. 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 (+492518345781, alexander.oberhuber@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from target vessel instability (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 26 Mar 2024.