Clinical 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. 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.
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).
