WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST)

March 13, 2023 updated by: Microvention-Terumo, Inc.
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The following parameters will be evaluated as part of this study:

  • Aneurysm morphology
  • Aneurysm size
  • For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)
  • Size of the embolization device(s) used in the procedure
  • Intra-procedural assessment of aneurysm occlusion and flow stasis
  • Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)
  • Aneurysm occlusion durability
  • Recanalization rate
  • Device-related changes in Modified Rankin Scale from baseline
  • Complications/adverse events
  • Rebleed/new bleed

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Clichy, France, 92118
        • Hopital Beaujon
      • Montpellier, France, 34295
        • CHU Gui de Chauliac
      • Reims, France, 51092
        • CHU Reims Maison Blanche
      • Toulouse, France, 31059
        • CHU Purpan
      • Tours, France, 37000
        • Chu Bretonneau
  • Germany
      • Cologne, Germany, 50937
        • Uniklinik Koeln
      • Erfurt, Germany, 99089
        • Helios Klinikum
      • Frankfurt, Germany, 60528
        • Klinikum Der Johann Wolfgang Goethe Universitat
      • Recklinghausen, Germany, 45657
        • Klinikum VEST GmbH
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart- Katharinenhospital
  • Hungary
      • Budapest, Hungary, H-1145
        • National Institute of Neurosciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with:

- Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use

Description

Inclusion Criteria:

  • Must be at least 18 years of age
  • Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures

Exclusion Criteria:

  • Must not have clinical or angiographic evidence of vasospasm
  • Must not have lesion with characteristics unsuitable for endovascular treatment
  • Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
  • Must not be concurrently involved in another investigational or post-market study
  • Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Index Embolization Cohort
WEB Aneurysm Embolization System
Procedure: Intracranial aneurysm embolization
Treatment of intracranial aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durability of occlusion
Time Frame: 6 months
Evaluated by the Corelab
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence/recanalization rate
Time Frame: 6 months
Evaluated by the Corelab, based on Raymond Roy occlusion scale
6 months
Modified Raymond Scale
Time Frame: 6 months
Evaluation of patient's functional level of activity by the physician
6 months
Percentage occlusion of target aneurysm
Time Frame: 6 months
Evaluated by the Corelab
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoroscopy time
Time Frame: procedure
Duration of fluoroscopy time will be recorded during the procedure
procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: Laurent Pierot, MD, CHU Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 11-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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