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NCT05665309 Clinical Trial

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

Intracranial Aneurysm Clinical Trial

— ILIAD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05665309
Other study ID # 2022/676
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date December 2025

Study information
Verified date September 2023
Source Centre Hospitalier Universitaire de Besancon
Contact Guillaume CHARBONNIER, MD
Phone +33381668502
Email g1charbonnier@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 3D anatomical model of aneurysm
Surgery prepared with 3D anatomical model of aneurysm

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Day 0
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