Abdominal Aortic AneurysmsFenSimNCT03469245
Validation of Fenestrations Positioning by Numerical Simulation
An observational study of Abdominal Aortic Aneurysms, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in 5 countries.
Trial summary
Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- numerical simulation
- How many people
- 50 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 26 Apr 2018to 22 Sep 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 have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included.
Who may be able to join
- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device
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)
- stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
- patient refusing to participate to the study
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
France4 sites
CHU Bordeaux
Bordeaux
CHU Lyon
Lyon
Hôpitaux privés de Metz
Metz
Chu Saint-Etienne
Saint-Etienne
Netherlands2 sites
Rijnstate Hospital
Arnhem
University Hospital Utrecht
Utrecht
About this study
Official title: Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms
Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.
Read the detailed description
The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.
The goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at Vascutek and the one by numerical simulation performed by Predisurge company.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- numerical simulation
- Keywords
- Endovascular, Fenestrated endovascular repair, numerical simulation
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
numerical simulationOther
After patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek.
| Study group | Role | What they receive |
|---|---|---|
| abdominal aortic aneurysms treated by fenestrated endovascular | Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation. Receives: Other: numerical simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascutek in vitro validation test and the numerical simulation
To compare Vascutek in vitro validation test and the numerical simulation (Predisurge). The proportion of fenestrations is less or equal to 2.5mm will be calculated.
Measured: Months: 18
Secondary outcomes (2)
initial and final stent-graft designs obtained from Vascutek
To study differences between initial and final stent-graft designs obtained from Vascutek process, the differences between L2 and L1 and C2 to C1 will be computed:
L = for each fenestration, the longitudinal distance between centre of fenestration and top of fabric C = for each fenestration, circumferential angular distance between O° line and center of fenestration
Current Vascutek protocol:
- Initial custom Stent Graft design, right before in vitro testing = L1 and C1
- Final custom Stent Graft design, after in vitro tests and subsequent design changes =L2 and C2
Measured: Months: 18
stent-graft designs obtained from simulation of deployment
To study differences between stent-graft designs obtained from simulation of deployment in the polymer model and from simulation of deployment in the patient, the differences between L4 and L3 and C4 to C3 will be computed:
L = for each fenestration, the longitudinal distance between centre of fenestration and top of fabric C = for each fenestration, circumferential angular distance between O° line and center of fenestration
Simulation for fenestration positioning:
- Initial custom Stent Graft design, right before in vitro testing = L3 and C3
- Final custom Stent Graft design, after in vitro tests and subsequent design changes =L4 and C4
Measured: Months: 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start26 Apr 2018
- Primary completion4 Sep 2019
- Study completion22 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Predisurge Society
- Responsible party
- Sponsor
- Investigators
- Bertrand CHAVENT, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469245
- Sponsor's protocol ID
- IRBN762017
- Acronym
- FenSim
- Status last verified
- Jan 2021
- First submitted
- 19 Feb 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03469245
- Acronym / sponsor ID
- FenSim / IRBN762017
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Endovascular, Fenestrated endovascular repair, numerical simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Predisurge Society
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 22 Sep 2019 (actual)
- First posted
- 19 Mar 2018 (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.
Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.
Detailed description
The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.
The goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at Vascutek and the one by numerical simulation performed by Predisurge company.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abdominal aortic aneurysms treated by fenestrated endovascular | – | Other: numerical simulationPatients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included.
Key inclusion criteria (1 listed)
- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device
Key exclusion criteria (3 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)
- stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
- patient refusing to participate to the study
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 |
|---|---|---|
| numerical simulationAfter patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek. | Other | abdominal aortic aneurysms treated by fenestrated endovascular |
Primary outcome
Vascutek in vitro validation test and the numerical simulation
Time frame: Months: 18
To compare Vascutek in vitro validation test and the numerical simulation (Predisurge). The proportion of fenestrations is less or equal to 2.5mm will be calculated.
2 secondary outcomes
initial and final stent-graft designs obtained from Vascutek
Time frame: Months: 18
stent-graft designs obtained from simulation of deployment
Time frame: Months: 18
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 22 Jun 2023.
- 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.
Bertrand CHAVENT, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in 5 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 3 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Netherlands, Austria, Germany, United Kingdom. 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?
Vascutek in vitro validation test and the numerical simulation (time frame: Months: 18). 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 22 Jun 2023.