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

September 26, 2023 updated by: Centre Hospitalier Universitaire de Besancon
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/676

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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