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

Centre Hospitalier Universitaire de Besancon

Status: Not yet enrolling

Conditions: Intracranial Aneurysm

Treatments: Procedure: 3D anatomical model of aneurysm

Study type: Interventional

Funder types: Other

Identifiers

NCT05665309

2022/676

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

With 3D anatomical model

Experimental group

Description:

Surgery prepared using 3D anatomical model of the aneurysm

Treatment:

Procedure: 3D anatomical model of aneurysm

Without 3D anatomical model

No Intervention group

Description:

Surgery prepared without 3D anatomical model of the aneurysm (routine care)