Aneurysm CerebralAnev3DNCT05419661
Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms
A study testing Operational Pre-Planning in people with Aneurysm Cerebral, run by University Hospital, Brest at 1 site in France.
Trial summary
It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immediately, in 30% to 50% death within three weeks and in 30% of cases the patients will present a permanent disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- Operational Pre-Planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2026to 1 Jun 2029
- Phase
- Interventional
- 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
Who may be able to join
- Patient over 18 years old
- Social security affiliation
- Patient who signed inform consent form
- Patient with an unruptured saccular carotid-sylvian aneurysm of more than 4 mm in long axis and less than 20 mm
- Primary preventive treatment decision validated in CPR
- Patient having benefited from a 3DRA during a previous arteriography dating from less than 6 months, or whose cerebral arteriography is planned less than 2 weeks before the intervention
Who cannot join
- Unable or unwilling to come for follow-up appointments
- Weight > 250kg due to weight limits on the angiographic table
- Allergy to iodinated contrast agents
- Patient with a contraindication to MRI
- Pregnancy, breastfeeding or planning to become pregnant in the following year
- Limited life expectancy < 1 year
Show all 15Show fewer
- Patient participating in another clinical study or having completed their participation less than 30 days ago
- Patient under legal protection, Patient under guardianship or curatorship
- Kidney failure, GFR < 60ml/min/1.73 m2
- Platelets < 50 x 10 ^ 9/L
- Partially thrombosed aneurysm
- Partially calcified aneurysm
- Recanalized or previously treated aneurysm (coils, stent, clip, flow disrupter)
- Another aneurysm on the same carrier artery already treated (coils, stent, clip, flow disrupter)
- Ruptured aneurysm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Pr Gentric Jean-Christophe
Brest
Jean-Christophe Gentric, Pr, 0298347802, jean-christophe.gentric@chu-brest.fr
About this study
Official title: Evaluation of the Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms
It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immediately, in 30% to 50% death within three weeks and in 30% of cases the patients will present a permanent disability. The management of this pathology represents today a major health challenge. Historically, neurosurgery was the discipline of first choice for the treatment of this pathology. This consists of clipping the aneurysm by a surgical approach to exclude it from the blood circulation and thus avoid its rupture. For many years now, interventional neuroradiology has established itself, through its "minimally invasive" and endovascular approach, as the reference treatment for ruptured and non-ruptured intracranial aneurysms: this is embolization. This so-called minimally invasive technique consists of placing directly into the aneurysm, using micro-catheters that are navigated under radiological control from the femoral artery, turns of plates called "coils" or prostheses called " stent" or "flow-diverter". This technique makes it possible to secure the aneurysm from the inside and thus reduce the risk of rupture. Today, 95% of patients are treated using this innovative technique and limited intraoperative risks. Interventional neuroradiology has constantly known in recent years a set of revolutions and innovations in terms of implantable medical devices (IMD) allowing to treat more and more patients with excellent clinical results. Today, the interventional neuroradiologist, assisted by the radiographer, has a very wide range of IMDs that he can combine with each other depending on the type, location, size and shape of the aneurysm. The role of the manipulator, here, is to work closely with the neuroradiologist so that he has, on the one hand, quality images and on the other hand, that he can count on a precious ally, an expert in IMDs, during embolization procedures. However, the wide choice of medical devices and the complexity of the aneurysms to be treated sometimes make treatment complicated. On the day of the "cold" treatment of the aneurysm (i.e. non-ruptured), the technicality of the catheterization and aneurysm's spatial conformation complicates the deployment of embolization equipment. This then sometimes leads to undesirable events such as intraoperative rupture. The very purpose of this study is to be able, by means of a 3D printer, to print the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus proceed to a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment.
Read the detailed description
The indication of a primary preventive treatment by endovascular route will be posed in a multidisciplinary consultation meeting of neurovascular pathology for patients who have accidentally discovered a carotid-sylvian cerebral aneurysm (not ruptured).
During the treatment announcement consultation carried out by an interventional neuroradiologist taking place, generally less than a month, after the staff, the latter may propose the study to the patient. The investigator gives him the information letter. The patient will benefit from a reflection period of one week and will be contacted by telephone by the MERM to validate or not his wish to participate in the study.
The random selection of patients is carried out in consultation during the inclusion visit (consultation with the MERM). The pre-operative course will be carried out according to the usual scheme in the 2 groups. Unlike the control group (PPO-), the PPO+ group will have a parallel PPO (Pre-Planning Operative). The intracranial aneurysm embolization treatment procedure will then be performed in both groups.
The duration of the study is a maximum of 6 months per participant, including a maximum interval of 2 months between the inclusion visit and the treatment (usual coverage period between the treatment announcement consultation and the intervention) and 4 months of follow-up (end-of-study visit at M4).
- Conditions
- Aneurysm Cerebral
- Being tested
- Operational Pre-Planning
- Keywords
- Operational Pre-Planning, embolization, 3D printer, carotid-sylvian aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operational Pre-PlanningOther
Also called PPO
Using a 3D printer, printing of the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus allowing a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment.
| Study group | Role | What they receive |
|---|---|---|
| PPO + | Experimental | Operational Pre-Planning + intracranial aneurysm embolization treatment Receives: Other: Operational Pre-Planning |
| PPO - | No intervention | Only intracranial aneurysm embolization treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate during implantation of the first two implantable devices chosen, failure being defined as non-implantation of one of the first two implantable devices used.
Measured: 15 months
Secondary outcomes (8)
Number of attempts to implant a device
Measured: 15 months
device usage time
Catheterization's time and implantation's time
Measured: 15 months
Operative time
time between placement of intermediate catheters in the internal carotid artery and final control
Measured: 15 months
Quantity of X-radiation
Measured: 15 months
Quantity of iodinated contrast product
Measured: 15 months
General anesthesia time
Measured: 15 months
Number of per-procedure adverse events
Measured: 15 months
Number of complications related to the procedure
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm CerebralStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419661
- Sponsor's protocol ID
- 29BRC20.0132
- Acronym
- Anev3D
- Status last verified
- Jun 2026
- First submitted
- 23 May 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms
- ClinicalTrials.gov ID
- NCT05419661
- Acronym / sponsor ID
- Anev3D / 29BRC20.0132
- Conditions
- Aneurysm Cerebral
- Keywords
- Operational Pre-Planning, embolization, 3D printer, carotid-sylvian aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 15 Jun 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.
It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immediately, in 30% to 50% death within three weeks and in 30% of cases the patients will present a permanent disability. The management of this pathology represents today a major health challenge. Historically, neurosurgery was the discipline of first choice for the treatment of this pathology. This consists of clipping the aneurysm by a surgical approach to exclude it from the blood circulation and thus avoid its rupture. For many years now, interventional neuroradiology has established itself, through its "minimally invasive" and endovascular approach, as the reference treatment for ruptured and non-ruptured intracranial aneurysms: this is embolization. This so-called minimally invasive technique consists of placing directly into the aneurysm, using micro-catheters that are navigated under radiological control from the femoral artery, turns of plates called "coils" or prostheses called " stent" or "flow-diverter". This technique makes it possible to secure the aneurysm from the inside and thus reduce the risk of rupture. Today, 95% of patients are treated using this innovative technique and limited intraoperative risks. Interventional neuroradiology has constantly known in recent years a set of revolutions and innovations in terms of implantable medical devices (IMD) allowing to treat more and more patients with excellent clinical results. Today, the interventional neuroradiologist, assisted by the radiographer, has a very wide range of IMDs that he can combine with each other depending on the type, location, size and shape of the aneurysm. The role of the manipulator, here, is to work closely with the neuroradiologist so that he has, on the one hand, quality images and on the other hand, that he can count on a precious ally, an expert in IMDs, during embolization procedures. However, the wide choice of medical devices and the complexity of the aneurysms to be treated sometimes make treatment complicated. On the day of the "cold" treatment of the aneurysm (i.e. non-ruptured), the technicality of the catheterization and aneurysm's spatial conformation complicates the deployment of embolization equipment. This then sometimes leads to undesirable events such as intraoperative rupture. The very purpose of this study is to be able, by means of a 3D printer, to print the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus proceed to a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment.
Detailed description
The indication of a primary preventive treatment by endovascular route will be posed in a multidisciplinary consultation meeting of neurovascular pathology for patients who have accidentally discovered a carotid-sylvian cerebral aneurysm (not ruptured).
During the treatment announcement consultation carried out by an interventional neuroradiologist taking place, generally less than a month, after the staff, the latter may propose the study to the patient. The investigator gives him the information letter. The patient will benefit from a reflection period of one week and will be contacted by telephone by the MERM to validate or not his wish to participate in the study.
The random selection of patients is carried out in consultation during the inclusion visit (consultation with the MERM). The pre-operative course will be carried out according to the usual scheme in the 2 groups. Unlike the control group (PPO-), the PPO+ group will have a parallel PPO (Pre-Planning Operative). The intracranial aneurysm embolization treatment procedure will then be performed in both groups.
The duration of the study is a maximum of 6 months per participant, including a maximum interval of 2 months between the inclusion visit and the treatment (usual coverage period between the treatment announcement consultation and the intervention) and 4 months of follow-up (end-of-study visit at M4).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPO + | Experimental | Other: Operational Pre-PlanningOperational Pre-Planning + intracranial aneurysm embolization treatment |
| PPO - | No intervention | –Only intracranial aneurysm embolization treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient over 18 years old
- Social security affiliation
- Patient who signed inform consent form
- Patient with an unruptured saccular carotid-sylvian aneurysm of more than 4 mm in long axis and less than 20 mm
- Primary preventive treatment decision validated in CPR
Key exclusion criteria (15 listed)
- Unable or unwilling to come for follow-up appointments
- Weight > 250kg due to weight limits on the angiographic table
- Allergy to iodinated contrast agents
- Patient with a contraindication to MRI
- Pregnancy, breastfeeding or planning to become pregnant in the following year
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 |
|---|---|---|
| Operational Pre-PlanningAlso: PPOUsing a 3D printer, printing of the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus allowing a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment. | Other | PPO + |
Primary outcome
Failure rate during implantation of the first two implantable devices chosen, failure being defined as non-implantation of one of the first two implantable devices used.
Time frame: 15 months
8 secondary outcomes
Number of attempts to implant a device
Time frame: 15 months
device usage time
Time frame: 15 months
Operative time
Time frame: 15 months
Quantity of X-radiation
Time frame: 15 months
Quantity of iodinated contrast product
Time frame: 15 months
General anesthesia time
Time frame: 15 months
Number of per-procedure adverse events
Time frame: 15 months
Number of complications related to the procedure
Time frame: 15 months
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operational Pre-Planning in people with Aneurysm Cerebral, run by University Hospital, Brest at 1 site in France.
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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 9 Jun 2026. 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 France. 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 Samuel GUIGO (+330298347532, samuel.guigo@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate during implantation of the first two implantable devices chosen, failure being defined as non-implantation of one of the first two implantable devices used. (time frame: 15 months). 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 9 Jun 2026.