Back to resultsAnalysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms (ACET)
Primary Purpose
Unruptured Intracranial Aneurysms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diffusion-weighted MRI and clinical examination
Sponsored by
About this trial
This is an interventional basic science trial for Unruptured Intracranial Aneurysms
Eligibility Criteria
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
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient with endovascular treatment
Arm Description
Outcomes
Primary Outcome Measures
Thromboembolic complication
Thromboembolic complication diagnosed using diffusion-weighted MRI
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02862756
Brief Title
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms
Acronym
ACET
Official Title
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Intracranial Aneurysms
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with endovascular treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
diffusion-weighted MRI and clinical examination
Primary Outcome Measure Information:
Title
Thromboembolic complication
Description
Thromboembolic complication diagnosed using diffusion-weighted MRI
Time Frame
72 hours after endovascular treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms
We'll reach out to this number within 24 hrs