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Analysis 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
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Unruptured Intracranial Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 8, 2016
Last Updated
May 12, 2021
Sponsor
CHU de Reims
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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

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