NCT04621552

Brief Summary

Selection of the appropriate size of the device is mandatory during aneurysm treatment with a WEB. The Investigators aimed to investigate if virtual simulation with Sim\&Size software may have an impact on technical, angiographic, and clinical outcomes after WEB treatment. Data from two large-volume centers were collected and compared (January 2017-January 2020). Virtual simulation was systematically adopted in one center, while conventional sizing was used in the other one. Outcomes were the duration of intervention, the radiation dose (mGy), the number of corrective interventions for inappropriate WEB size, the number of WEBs not deployed, angiographic occlusion, and complications. Univariate and multivariate linear models were adopted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

5.5 years

First QC Date

November 3, 2020

Last Update Submit

November 9, 2020

Conditions

AneurysmIntracranial Aneurysm

Keywords

Intracranial AneurysmWEBvirtual simuationSARS-CoV-2Unruptured and Ruptrued intracranial aneurysms

Outcome Measures

Primary Outcomes (4)

  • Median duration of the intervention

    the median duration of the intervention

    1day

  • Median radiation dose

    the median radiation dose

    1 day

  • Need of corrective interventions

    the need of corrective interventions

    1 day

  • number of WEBs opened

    the number of WEBs opened but finally not deployed because of the inappropriate size of the device.

    1 day

Secondary Outcomes (4)

  • Overall rate of complications

    1 day

  • morbidity rate

    1 day

  • Rate of Aneurysm occlusion

    6 months and 12 months

  • WEB-shape change

    6 months and 12 months

Interventions

WEB embolizationDEVICE

Treatment of intracranial aneurysms with WEB with the use of the virtual simulation before implantation of the device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients \>18 years treated with WEB for an intracranial aneurysms

You may qualify if:

  • \- Patients \> 18 years treated with WEB for intracranial aneuryms

You may not qualify if:

  • Patients \<18 years
  • no eligibility for treatment with WEB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Cagnazzo F, Marnat G, Ferreira I, Daube P, Derraz I, Dargazanli C, Lefevre PH, Gascou G, Riquelme C, Morganti R, Berge J, Gariel F, Barreau X, Costalat V. Comparison of Woven EndoBridge device sizing with conventional measurements and virtual simulation using the Sim&Size software: a multicenter experience. J Neurointerv Surg. 2021 Oct;13(10):924-929. doi: 10.1136/neurintsurg-2020-017060. Epub 2020 Dec 23.

    PMID: 33361275DERIVED

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

AneurysmIntracranial Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Federico Cagnazzo, MD PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

January 1, 2015

Primary Completion

June 30, 2020

Study Completion

October 30, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

FR(1)