Clincosm LogoSign in Get a demo

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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05665309
Collaborator
(none)
60
Enrollment
2
Arms
3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 3D anatomical model of aneurysm
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: With 3D anatomical model

Surgery prepared using 3D anatomical model of the aneurysm

Procedure: 3D anatomical model of aneurysm
Surgery prepared with 3D anatomical model of aneurysm
No Intervention: Without 3D anatomical model

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Guillaume CHARBONNIER, MD, CHU de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT05665309
Other Study ID Numbers:
  • 2022/676
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm

Study Results

No Results Posted as of Dec 27, 2022