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

NCT ID: NCT05665309

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

With 3D anatomical model

Surgery prepared using 3D anatomical model of the aneurysm

Group Type EXPERIMENTAL

3D anatomical model of aneurysm

Intervention Type PROCEDURE

Surgery prepared with 3D anatomical model of aneurysm

Without 3D anatomical model

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3D anatomical model of aneurysm

Surgery prepared with 3D anatomical model of aneurysm

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guillaume CHARBONNIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Guillaume CHARBONNIER, MD

Role: CONTACT

+33381668502

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022/676

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Venous Sinus Stenting With the River Stent in IIH
NCT03556085 ACTIVE_NOT_RECRUITING NA
Diffusion Spectroscopy in Stroke
NCT02833961 COMPLETED NA