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Virtual Simulation for Woven EndoBridge Device Sizing

NCT04621552 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 186

Last updated 2020-11-10

No results posted yet for this study

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.

Conditions

  • Aneurysm
  • Intracranial Aneurysm

Interventions

DEVICE

WEB embolization

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

Sponsors & Collaborators

  • University Hospital, Bordeaux

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Federico Cagnazzo, MD PhD · UH Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2020-06-30
Completion
2020-10-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04621552 on ClinicalTrials.gov