Analysis of Thrombo-embolic Complications After Endovascu... | NCT02862756

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

NCT02862756

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

May 13, 2021Actual

Enrollment

250Actual

Phase

Not Applicable

Conditions

Unruptured Intracranial Aneurysms

Interventions

diffusion-weighted MRI and clinical examination

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 14, 2016Actual

Primary Completion Date

Mar 12, 2020Actual

Completion Date

Mar 9, 2021Actual

First Submitted Date

Aug 8, 2016

First Submission Date that Met QC Criteria

Aug 8, 2016

First Posted Date

Aug 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2021

Last Update Posted Date

May 13, 2021Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient with endovascular treatment	Experimental		Other: diffusion-weighted MRI and clinical examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diffusion-weighted MRI and clinical examination	Other		patient with endovascular treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thromboembolic complication	Thromboembolic complication diagnosed using diffusion-weighted MRI	72 hours after endovascular treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Chu de Reims		Reims		51092	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39095086	Derived	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.

ID	Term
D032763	Behavior Control
D013812	Therapeutics
D007103	Immobilization
D008919	Investigative Techniques