Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms (ACET)
May 12, 2021 updated by: CHU de Reims
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this multicenter, prospective study, patients with treatment of unruptured intracranial aneurysms will be recruited.
The thromboembolic complications will be research using diffusion-weighted MRI.
Study Type
Interventional
Enrollment (Actual)
250
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 Locations
-
-
-
Reims, France, 51092
- CHU de Reims
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients with contraindications for MRI
- patients whose clinical condition does not allow sufficient cooperation to the realization of MRI
- patients with arteriovenous malformation intracranial
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patient with endovascular treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thromboembolic complication
Time Frame: 72 hours after endovascular treatment
|
Thromboembolic complication diagnosed using diffusion-weighted MRI
|
72 hours after endovascular treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
November 14, 2016
Primary Completion (Actual)
March 12, 2020
Study Completion (Actual)
March 9, 2021
Study Registration Dates
First Submitted
August 8, 2016
First Submitted That Met QC Criteria
August 8, 2016
First Posted (Estimate)
August 11, 2016
Study Record Updates
Last Update Posted (Actual)
May 13, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR16021*
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.