CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms (CLARYS)

January 25, 2023 updated by: Microvention-Terumo, Inc.

CLinical Assessment of WEB® Device in Ruptured aneurYSms

An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All eligible subjects presenting to the participating Registry Center will be considered for entry into the Registry. Up to 70 evaluable subjects meeting the Registry entry criteria will be enrolled.

An intermediary analysis will be performed when the first forty (40) subjects reaching the planned one month follow-up.

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

Study Type

Observational

Enrollment (Actual)

60

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-Bicetre, France, 94270
        • Service de Neuroradiologie

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 Registry

Description

Inclusion Criteria:

  1. 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 Registry
  2. Subject must be ≥ 18 years and < 80 years of age
  3. Subject must have a single intracranial aneurysm ruptured within 30 days requiring treatment according to a multidisciplinary decision Definition: For the purposes of this study a ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days.
  4. If the subject has one or more additional aneurysm, the additional aneurysm must not require treatment in emergency or within 30 days of the index procedure
  5. Subject with Hunt & Hess Score of I, II or III
  6. Conventional or Flat-panel CT is performed within 6hrs prior to femoral puncture (or just before WEB placement if any clinical worsening is noted before the treatment) to assess absence of re-bleeding prior the treatment

  7. Aneurysm to be treated must have the following characteristics i. Morphology - saccular ii. Location

    • Basilar apex (BA), or
    • Middle cerebral artery (MCA) bifurcation, or
    • Internal carotid artery (ICA) terminus, or
    • Anterior communicating artery (ACom), or
    • Anterior cerebral Artery (ACA), or
    • Posterior Communicating (PCom) iii. Diameter and height of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use: Max width diameter 10mm iv. Aneurysm is a priori intended to be treated only with WEB
  8. Subject must be considered by the physician to be available for subsequent visits
  9. Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
  10. Subject, or its legal representative, must have received information regarding the data collection and data protection within this clinical evaluation, or must have signed the informed consent when locally mandatory.

Exclusion Criteria:

  1. Subject is greater than 80 years of age
  2. Subject has a Hunt & Hess Score of IV or V
  3. Subject has more than one aneurysm requiring treatment within 30 days of index procedure
  4. Maximum aneurysm width is >10mm
  5. Subject is female and pregnant or breast-feeding
  6. Subject has a known coagulopathy
  7. Subject has a known hemoglobinopathy or thrombocytopathy
  8. Subject has lesion with characteristics unsuitable for endovascular treatment
  9. Subject has vessel, tortuosity or morphology which could preclude safe access and support during treatment with clinical evaluation device
  10. Subject has physical, neurologic or psychiatric conditions, which preclude Subject's ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
  11. Subject has known hypersensitivity, which can not be treated, to any component of the clinical evaluation device, procedural materials, or medications commonly used during the procedure
  12. Subject has received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
  13. Subject has an acute life-threatening illness other than the neurological disease to be treated in this trial
  14. Subject has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm) Imaging Exclusion criteria
  15. An additional aneurysm need to be treated during the index procedure
  16. Microcatheter cannot reach Subject's aneurysm to allow necessary access to treat with WEB.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
WEB Aneurysm Embolization System
Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms.
Device: WEB Aneurysm Embolization System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-Bleed rate after treatment
Time Frame: 1 month

Re-bleeding rate after treatment of the target aneurysm with WEB, during the period extending from post-procedure up to 1 month.

Definitions:

  1. Re-bleeding from target aneurysm is defined as patent evidence of hemorrhage on CT or MRI AND hemorrhage is depicted in the same territory as the initial bleeding AND hemorrhage has increased in size compare to initial pre-operative CT
  2. Screening for re-bleeding: During hospital stay of the patient and up to 1-month, any worsening of the clinical status should lead to perform a non-enhanced CT or MRI.

Or, as per-center standard care, non-enhanced CT or MRI might be performed systematically during hospital course.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneurysm occlusion
Time Frame: 12 months
Angiographic (conventional or CT-Angio or MR-Angio) occlusion at 12month based on WEB occlusion scale (WOS)
12 months

Collaborators and Investigators

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

Sponsor

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: Laurent Spelle, MD, PhD, CHU Bicêtre

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

January 1, 2016

Primary Completion (Actual)

October 10, 2017

Study Completion (Actual)

December 4, 2018

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP15-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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