Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT05665309
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision
- Consent form signed
- The patient benefits from health insurance
- Legal incapacity
- Women at risk of pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.