Intracranial Aneurysm
Conditions
Brief summary
This is a preliminary randomised controlled trial comparing the use of pre-operative 3D models to select an intrasaccular flow disruptor for endovascular aneurysm cure.
Detailed description
Patients will be randomised 3:1 either in the intervention or control group. Intervention consists of using the pre-operative Digital Subtraction Angiography (DSA) to create a 3D plastic model. This model is used to test different sizes of device. At the end of this pre-operative test a single device is recommended for the real procedure. The control group will use the current method for size selection (measurement of mean width and minimum height) on DSA.
Interventions
PROCEDURE3D anatomical model of aneurysm
Surgery prepared with 3D anatomical model of aneurysm
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision * Consent form signed * The patient benefits from health insurance
Exclusion criteria
* Legal incapacity * Women at risk of pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with successful procedure | Day 0 | Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor |
Contacts
Primary ContactGuillaume CHARBONNIER, MD
Outcome results
None listed