Aortic Arch AneurysmNCT04244188
Simulation of Stent-graft Deployment in Aortic Arch Aneurysms
An observational study of Aortic Arch Aneurysm, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in 2 countries.
Trial summary
Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Arch Aneurysm
- What is being tested?
- Collection of datas
- How many people
- 4 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2019to 31 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included.
Who may be able to join
- Aortic arch aneurysms suitable for treatment using double-branched device Bolton
Who cannot join
- Failure to generate an adequate FE model of patient arteries (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CT-scan slice thickness greater than 1mm, preoperative CT- scan with artifacts)
- dissected aneurysm
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.
Read the detailed description
The process of numerical simulation of double-branched device in aortic arch aneurysm involves: (i) aortic arch segmentation with data from the preoperative CT-scan (ii) numerical modeling of the actual stentgraft used to treat the patient (iii) simulation of stentgraft deployment in aortic arch (iv) validation of simulation results based on post-operative CT scan images The goal of this study is to develop a numerical model of stentgraft deployment able to predict the actual deployement of the double branched device in aortic arch aneurysm.
- Conditions
- Aortic Arch Aneurysm
- Being tested
- Collection of datas
- Keywords
- Numerical simulation, stent-graft, aortic arch aneurysms
- Medical subject headings
- Aneurysm, Aortic Arch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of datasOther
Collection of datas: pre- and postoperative scanner and endoprosthesis characteristics
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for aortic arch aneurysms | Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included. Receives: Other: Collection of datas |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro versus stimulation test
To compare Vascutek in vitro validation test to the simulation of this test, the proportion of fLenestrations where |L3 - L2| and |C3 - C2| are less or equal to 2.5mm will be analysed.
L3=distal edge of celiac trunk (L) after first simulation, stent-graft deployment in rigid aorta L2=distal edge of celiac trunk (L) after final custom stent-graft design, after in vitro tests
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Jan 2019
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Arch AneurysmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Noël ALBERTINI, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244188
- Sponsor's protocol ID
- IRBN032019/CHUSTE
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derycke L, Perrin D, Cochennec F, Albertini JN, Avril S. Predictive Numerical Simulations of Double Branch Stent-Graft Deployment in an Aortic Arch Aneurysm. Ann Biomed Eng. 2019 Apr;47(4):1051-1062. doi: 10.1007/s10439-019-02215-2. Epub 2019 Jan 31.
PubMed 30706308
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation of Stent-graft Deployment in Aortic Arch Aneurysms
- ClinicalTrials.gov ID
- NCT04244188
- Acronym / sponsor ID
- IRBN032019/CHUSTE
- Conditions
- Aortic Arch Aneurysm
- Keywords
- Numerical simulation, stent-graft, aortic arch aneurysms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 28 Jan 2020 (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.
Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.
Detailed description
The process of numerical simulation of double-branched device in aortic arch aneurysm involves: (i) aortic arch segmentation with data from the preoperative CT-scan (ii) numerical modeling of the actual stentgraft used to treat the patient (iii) simulation of stentgraft deployment in aortic arch (iv) validation of simulation results based on post-operative CT scan images The goal of this study is to develop a numerical model of stentgraft deployment able to predict the actual deployement of the double branched device in aortic arch aneurysm.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for aortic arch aneurysms | – | Other: Collection of datasPatients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included.
Key inclusion criteria (1 listed)
- Aortic arch aneurysms suitable for treatment using double-branched device Bolton
Key exclusion criteria (2 listed)
- Failure to generate an adequate FE model of patient arteries (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CT-scan slice thickness greater than 1mm, preoperative CT- scan with artifacts)
- dissected aneurysm
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 |
|---|---|---|
| Collection of datasCollection of datas: pre- and postoperative scanner and endoprosthesis characteristics | Other | Patients treated for aortic arch aneurysms |
Primary outcome
In vitro versus stimulation test
Time frame: Day 0
To compare Vascutek in vitro validation test to the simulation of this test, the proportion of fLenestrations where |L3 - L2| and |C3 - C2| are less or equal to 2.5mm will be analysed. L3=distal edge of celiac trunk (L) after first simulation, stent-graft deployment in rigid aorta L2=distal edge of celiac trunk (L) after final custom stent-graft design, after in vitro tests
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 18 Nov 2023.
- Results publication: PubMed 30706308Derycke L, Perrin D, Cochennec F, Albertini JN, Avril S. Predictive Numerical Simulations of Double Branch Stent-Graft Deployment in an Aortic Arch Aneurysm. Ann Biomed Eng. 2019 Apr;47(4):1051-1062. doi: 10.1007/s10439-019-02215-2. Epub 2019 Jan 31.
- Individual participant dataSharing planned: No
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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.
Jean-Noël ALBERTINI, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 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 Arch Aneurysm, run by Centre Hospitalier Universitaire de Saint Etienne at 2 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 1 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, 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?
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?
In vitro versus stimulation test (time frame: Day 0). 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 NCT04244188, which also lists 1 linked publication.
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 18 Nov 2023.