Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor

Centre Hospitalier Universitaire de Besancon60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Intracranial Aneurysm

Interventions

3D anatomical model of aneurysmPROCEDURE

Surgery prepared with 3D anatomical model of aneurysm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor

Time frame: Day 0

Central Contacts

Guillaume CHARBONNIER, MD

CONTACT

+33381668502 g1charbonnier@chu-besancon.fr

Data from ClinicalTrials.gov

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