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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

Other trials in France

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).

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 groups in NCT05419661
Study groupRoleWhat they receive
PPO +ExperimentalOperational Pre-Planning + intracranial aneurysm embolization treatment
Receives: Other: Operational Pre-Planning
PPO -No interventionOnly intracranial aneurysm embolization treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Number of attempts to implant a device

    Measured: 15 months

  2. device usage time

    Catheterization's time and implantation's time

    Measured: 15 months

  3. Operative time

    time between placement of intermediate catheters in the internal carotid artery and final control

    Measured: 15 months

  4. Quantity of X-radiation

    Measured: 15 months

  5. Quantity of iodinated contrast product

    Measured: 15 months

  6. General anesthesia time

    Measured: 15 months

  7. Number of per-procedure adverse events

    Measured: 15 months

  8. 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.

  1. First posted15 Jun 2022
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

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)
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

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.

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