Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms

NCT05419661 | Not Yet Recruiting

• 1 other identifier: 29BRC20.0132
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aneurysm Cerebral

Keywords

Operational Pre-Planning; embolization; 3D printer; carotid-sylvian aneurysm

Outcome Measures

Primary Outcomes (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.

  15 months

Secondary Outcomes (8)

• Number of attempts to implant a device

  15 months

• device usage time

  15 months

• Operative time

  15 months

• Quantity of X-radiation

  15 months

• Quantity of iodinated contrast product

  15 months

Study Arms (2)

PPO +

EXPERIMENTAL

Operational Pre-Planning + intracranial aneurysm embolization treatment

Other: Operational Pre-Planning

PPO -

NO INTERVENTION

Only intracranial aneurysm embolization treatment

Interventions

Operational Pre-Planning OTHER

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.

Also known as: PPO

PPO +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Samuel GUIGO

CONTACT

+330298347532; samuel.guigo@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 15, 2022
• Study Start: April 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.