NCT02862756

Brief Summary

Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 14, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2021

Completed
Last Updated

May 13, 2021

Status Verified

March 1, 2021

Enrollment Period

3.3 years

First QC Date

August 8, 2016

Last Update Submit

May 12, 2021

Conditions

Unruptured Intracranial Aneurysms

Outcome Measures

Primary Outcomes (1)

  • Thromboembolic complication

    Thromboembolic complication diagnosed using diffusion-weighted MRI

    72 hours after endovascular treatment

Study Arms (1)

patient with endovascular treatment

EXPERIMENTAL
Other: diffusion-weighted MRI and clinical examination

Interventions

diffusion-weighted MRI and clinical examinationOTHER
patient with endovascular treatment

Eligibility Criteria

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

You may qualify if:

  • patient having a programmed endovascular treatment for unruptured intracranial aneurysm
  • patient older than 18 years
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program

You may not qualify if:

  • patients with contraindications for MRI
  • patients whose clinical condition does not allow sufficient cooperation to the realization of MRI
  • patients with arteriovenous malformation intracranial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

Related Publications (1)

  • Pierot L, Rouchaud A, Chabert E, Desal H, Ricolfi F, Barbe C, Soize S, Zerroug A, Eugene F, Clarencon F, Ferre JC. Endovascular treatment of unruptured intracranial aneurysms: Rate of thromboembolic events depicted by diffusion-weighted imaging in relation to different techniques. J Neurointerv Surg. 2025 Aug 13;17(9):949-955. doi: 10.1136/jnis-2024-022051.

    PMID: 39095086DERIVED

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

November 14, 2016

Primary Completion

March 12, 2020

Study Completion

March 9, 2021

Last Updated

May 13, 2021

Record last verified: 2021-03

Locations

FR(1)