Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

Unruptured Intracranial Aneurysms Clinical Trial

— ACET  

Official title:

Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862756
• Other study ID #: PR16021*
• Status: Completed
• Phase: N/A
• Start date: November 14, 2016
• Est. completion date: March 9, 2021

Study information

• Verified date: March 2021
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 9, 2021
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Unruptured Intracranial Aneurysms

Intervention

Other:
• diffusion-weighted MRI and clinical examination

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolic complication	Thromboembolic complication diagnosed using diffusion-weighted MRI	72 hours after endovascular treatment