Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms
NCT ID: NCT05419661
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-04-01
2026-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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PPO +
Operational Pre-Planning + intracranial aneurysm embolization treatment
Operational Pre-Planning
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.
PPO -
Only intracranial aneurysm embolization treatment
No interventions assigned to this group
Interventions
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Operational Pre-Planning
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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29BRC20.0132
Identifier Type: -
Identifier Source: org_study_id
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