NCT05665309

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

December 16, 2022

Last Update Submit

September 26, 2023

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

With 3D anatomical model

EXPERIMENTAL

Surgery prepared using 3D anatomical model of the aneurysm

Procedure: 3D anatomical model of aneurysm

Without 3D anatomical model

NO INTERVENTION

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

Interventions

3D anatomical model of aneurysmPROCEDURE

Surgery prepared with 3D anatomical model of aneurysm

With 3D anatomical model

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision
  • Consent form signed
  • The patient benefits from health insurance

You may not qualify if:

  • Legal incapacity
  • Women at risk of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Guillaume CHARBONNIER, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume CHARBONNIER, MD

CONTACT

+33381668502g1charbonnier@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

September 1, 2023

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09