CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms (CLEVER)

January 22, 2024 updated by: Microvention-Terumo, Inc.

CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.

Subjects will be followed per Institution's standard of care.

Study Type

Observational

Enrollment (Actual)

163

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

  • France
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre
      • Toulouse, France, 31059
        • Hopital Purpan
  • Germany
      • Bochum, Germany, 44892
        • Universitätsklinikum Knappschaftskrankenhaus
  • Hungary
      • Budapest, Hungary, 1145
        • National Institute of Clinical 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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this study

Description

Inclusion Criteria:

  1. Subject must be ≥ 18 years of age and ≤80 years of age
  2. Subject must have an intracranial aneurysm (IA),
  3. Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
  4. For ruptured aneurysm, Subject with Hunt & Hess Score ≤ III

Exclusion Criteria:

  1. Subject has an IA with characteristics unsuitable for endovascular treatment
  2. Subject's index IA was previously treated
  3. Subject has stroke-in-evolution within the prior 30 days
  4. An additional aneurysm must be treated during the procedure

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneurysm occlusion
Time Frame: 12 months

Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms.

  • class I: complete obliteration
  • class II: residual neck
  • class III: residual aneurysm
12 months
Incidence of major stroke or neurological deaths
Time Frame: 12months
The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
12months

Collaborators and Investigators

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

Sponsor

Microvention-Terumo, Inc.

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.

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 (Actual)

March 21, 2019

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP EMEA 18-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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