Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Enrollment
- 60
- Primary Endpoint
- Proportion of patients with successful procedure
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of patients with successful procedure
Time Frame: Day 0
Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor